|Publication number||US7771374 B2|
|Application number||US 11/401,674|
|Publication date||10 Aug 2010|
|Filing date||11 Apr 2006|
|Priority date||10 Dec 2001|
|Also published as||EP1627662A1, EP1627662B1, US20060259102|
|Publication number||11401674, 401674, US 7771374 B2, US 7771374B2, US-B2-7771374, US7771374 B2, US7771374B2|
|Original Assignee||Candela Corporation|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (98), Non-Patent Citations (3), Referenced by (36), Classifications (33), Legal Events (4)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims priority from EP Patent Application No. 050007952.4 (filed Apr. 12, 2005) and from IL Patent Application No. 170132 (filed Aug. 4, 2005), and is a Continuation-In-Part of U.S. patent application Ser. No. 11/057,542 (filed Feb. 14, 2005), which claims priority from Israeli Patent Application No. 160510 (filed on Feb. 22, 2004) and is a Continuation-In-Part of U.S. patent application Ser. No. 10/498,382 (filed Jun. 10, 2004), which is a Continuation-In-Part of PCT/IL02/00635 (filed on Aug. 2, 2002), which is derived from IL 147009 (filed on Dec. 10, 2001) and from IL 150094 (filed on Jun. 6, 2002).
The present invention is related to the field of light-based skin treatments. More specifically, the invention is related to the utilization of light sources for the non-invasive treatment of skin disorders under the skin surface, whereby light is selectively absorbed by hair shafts, blood vessels, or collagen bundles, for the treatment or destruction of unwanted hairs, of blood vessels, or of other skin disorders.
Prior art very high intensity, short duration pulsed light systems which operate in the visible part of the spectrum, such as flashlamps or intense pulsed lasers are currently used in aesthetic treatments by one of two known ways: a) Applying the light to the skin without applying any pressure on the treatment zone, so as not to interfere with the natural absorption properties of skin; and b) Applying pressure onto the skin by means of the exit window of the treatment device in contact with the skin, thereby expelling blood from the light path within the skin and enabling better transmission of the light to a skin target in cases where the spectral lines of the treatment light source match absorption lines of the blood.
The major applications of intense pulsed light or intense pulsed laser systems are hair removal, coagulation of blood vessels for e.g. port wine stains, telangectasia, spider veins and leg veins, multiple heating of blood vessels for e.g. rosacea, treatment of pigmented skin such as erasure of black stains and sun stains or tattoo removal, and removal of fine wrinkles by heating the tissue around the wrinkles, normally referred to as photorejuvenation.
U.S. Pat. Nos. 5,226,907, 5,059,192, 5,879,346, 5,066,293, 4,976,709, 6,120,497, 6,120,497, 5,626,631, 5,344,418, 5,885,773, 5,964,749, 6,214,034 and 6,273,884 describe various laser and non-coherent intense pulsed light systems. These prior art light systems are not intended to increase the natural absorption of the skin. These prior art light systems are also not intended to block pain transmission during treatments.
Applying a vacuum to the skin is a known prior art procedure, e.g. for the treatment of cellulites, which complements massaging the skin. Such a procedure produces a flow of lymphatic fluids so that toxic substances may be released from the tissue. As the vacuum is applied, a skin fold is formed. The skin fold is raised above the surrounding skin surface, and the movement of a handheld suction device across the raised skin performs the massage. The suction device is moved in a specific direction relative to the lymphatic vessels, to allow lymphatic fluids to flow in their natural flow direction. The lymphatic valve in each lymphatic vessel prevents the flow of lymphatic fluid in the opposite direction, if the suction device were moved incorrectly. Liquids generally accumulate if movement is not imparted to the raised skin. The massage, which is generally carried out by means of motorized or hand driven wheels or balls, draws lymphatic fluids from cellulite in the adipose subcutaneous region and other deep skin areas, the depth being approximately 5-10 mm below the dermis.
U.S. Pat. No. 5,961,475 discloses a massaging device with which negative pressure is applied to the skin together during massaging. A similar massaging device which incorporates a radio frequency (RF) source for the improvement of lymphatic flow by slightly heating the adipose tissue is described in U.S. Pat. No. 6,662,054. Some massaging systems, such as those produced by Deka and Cynosure, add a low power, continuous working (CW) light source of approximately 0.1-2 W/cm2, in order to provide deep heating of the adipose tissue by approximately 1-3° C. degrees and to enhance lymphatic circulation. The light sources associated with vacuum lymphatic massage devices are incapable of inducing blood vessel coagulation due to their low power. Also, prior art vacuum lymphatic massage devices are adapted to induce skin protrusion or to produce a skin fold by applying a vacuum.
Selective treatment of blood vessels by absorption of intense pulsed laser radiation is possible with Dye lasers operating at 585 nm, as well as with other types of lasers. Photorejuvenation has also been performed with Diode lasers in the near infrared spectral band of 800-980 nm and with Nd:YAG lasers having a frequency of approximately 1064 nm with limited success. The light emitted by such lasers is not well absorbed by tiny blood vessels or by the adjoining liquid. Broad band non-coherent intense pulsed light systems are also utilized for photorejuvenation with some success, although requiring more than 10 repeated treatments. The heat which is absorbed by the blood vessels, as a result of the light emitted by the intense short pulse devices, is transferred to adjacent collagen bundles.
The absorption of pulsed Diode and Nd:YAG laser beams by blood vessels is lower than the absorption of pulsed Dye laser beam. In order to compensate for limited photorejuvenation with red and infrared intense pulsed light and laser systems, a very high energy density as high as 30-60 J/cm2 needs to be generated. At such an energy density, the melanin-rich epidermis, particularly in dark skin, is damaged if not chilled. A method to reduce the energy density of intense pulsed lasers or non-coherent intense pulsed light sources which operate in the visible or the near infrared regions of the spectrum will thereforebe beneficial.
Pulsed dye lasers operating in the yellow spectral band of approximately 585-600 nm, which is much better absorbed by blood vessels, are also utilized for the smoothing of fine wrinkles. The energy density of light emitted by Dye lasers, which is approximately 3-5 J/cm2, is much lower than that of light emitted by other lasers. However, the pulse durations of light emitted by Dye lasers are very short, close to 1 microsecond, and therefore risk the epidermis in darker skin. Treatments of wrinkles with Dye lasers are slow, due to the low concentration of absorbing blood vessels, as manifested by the yellow or white color of treated skin, rather than red or pink characteristic of skin having a high concentration of blood vessels. Due to the low energy density of light emitted by Dye lasers, as many as 10 treatments may be necessary. A method to reduce the energy density of light generated by Dye lasers, or to reduce the number of required treatments at currently used energy density levels, for the treatment of fine wrinkles, would be beneficial.
Pulsed Dye lasers operating at 585 nm are also utilized for the treatment of vascular lesions such as port wine stains or telangectasia or for the treatment of spider veins. The energy density of the emitted light is approximately 10-15 J/cm2, and is liable to cause a burn while creating the necessary purpura. A method to reduce the energy density of light emitted by Dye lasers for the treatment of vascular lesions would be highly beneficial.
Hair removal has been achieved by inducing the absorption of infrared light, which is not well absorbed by melanin present in hair strands, impinging on blood vessels. More specifically, absorption of infrared light by blood vessels at the distal end of hair follicles contributes to the process of hair removal. High intensity pulsed Nd:YAG lasers, such as those produced by Altus, Deka, and Iridex, which emit light having an energy density of more than 50 J/cm2, are used for hair removal. The light penetration is deep, and is often greater than 6 millimeters. Some intense pulsed light or pulsed laser systems, such as that produced by Syneron, used for hair removal or photorejuvenation also employ an RF source for further absorption of energy within the skin.
The evacuation of smoke or vapor, which is produced following the impingement of monochromatic light on a skin target, from the gap between the distal end window of a laser system and the skin target, is carried out in conjunction with prior art ablative laser systems such as Co2, Erbium or Excimer laser systems. The produced smoke or vapor is usually purged by the introduction of external fresh air at greater than atmospheric pressure.
Coagulative lasers such as pulsed dye lasers or pulsed Nd:YAG lasers, which treat vascular lesions under the skin surface without ablating the skin surface, are generally not provided with an evacuation chamber which produces subatmospheric pressure over a skin target.
Some prior art intense pulsed laser systems, which operate in the visible and near infrared region of the spectrum and treat lesions under the skin surface, e.g. vascular lesions, with pulsed dye laser systems or pulsed Nd:YAG lasers, employ a skin chilling system. Humidity generally condenses on the distal window, due to the use of a skin chilling system. The humidity is not caused by the skin treatment, but rather by the low temperature of the distal window. It would be advantageous to evacuate the condensed vapors from the distal window of the laser system prior to the next firing of the laser.
U.S. Pat. Nos. 5,595,568 and 5,735,844 describe a coherent laser system for hair removal whereby pressure is applied to the skin by a transparent contact device in contact therewith, in order to expel blood present in blood vessels from a treatment zone. In this approach blood absorption decreases in order to increase subcutaneous light penetration.
U.S. Pat. Nos. 5,630,811 and 5,853,407 also describe a coherent laser system for hair removal which restricts local blood flow, in order to reduce damage to the skin tissue surrounding the hairs. Local tissue structures are flattened by applying positive pressure or negative pressure to the skin. The treatment beam is limited to only 5 mm. The treatment beam is not suitable for a larger treatment spot per pulse of approximately 40 mm. Also, the pressure level which has to be applied is not recited, although different pressures levels will lead to different effects. Some of these effects cannot be achieved with a beam diameter of 5 mm or less, as will be described hereinafter. Blood expulsion resulting from the pressing of skin is not uniform and is not instantaneous for such large treatment spots, and therefore blood may remain in the skin tissue after the laser beam has been fired. Also, a large-diameter treatment device may not be easily repositioned to another treatment site, due to the relatively high lifting force needed when negative pressure is applied to the skin. Furthermore, this laser system does not provide any means for preventing gel obstruction when negative pressure is applied to the skin. Although applying a flattening positive pressure or negative pressure to a small-diameter treatment area enhances hair removal, the treatment of vascular lesions is not improved since fewer blood vessels are present within the treatment area due to the blood expulsion. A need therefore exists for a vacuum-assisted device that can alternatively reduce or increase the blood volume fraction within a skin target.
US 2002/0128635 discloses a head for applying light energy to a selected depth in a scattering medium having an outer layer in physical and thermal contact with the head. The head includes a thermally conductive block having an energy emitting surface and at least one laser diode mounted in the block adjacent the energy emitting surface. At the bottom of the block is attached a transparent element having a high reflectivity mask with slits, for optimizing retroreflection of scattered energy from the skin. In one embodiment, the block is formed with a recess therein, into which a vacuum draws the skin. The head is not easily repositioned to another treatment site in order to treat a large-area skin surface, due to the relatively high lifting force needed when the vacuum is applied to the skin. Furthermore, means are not provided for preventing gel obstruction when a vacuum is applied to the skin.
The light-based non-ablative treatment of hair or of vascular lesions is often very painful, particularly during the treatment of dark and thick unwanted hairs which may appear in a bikini line, on the legs, or on the back. A pain sensation is felt with almost all types of light based devices for hair removal, including intense pulsed light sources and lasers.
The aforementioned prior art efforts to expel blood vessels help in some cases to avoid unnecessary damage to skin structures which are not intended to be treated, such as unnecessary coagulation of blood vessels during a hair removal treatment, while increasing hair removal efficacy. The reduction in damage to skin structures does not alleviate the immediate pain sensed during a treatment, but rather, the expulsion of blood causes a higher exposure of the hair shaft to a treatment pulse of light, resulting in a higher hair follicle temperature and a correspondingly higher level of acute pain due to excessive heating of the nerves which surround the hair shafts. Furthermore, the expelling of blood from one skin area increases the fractional blood volume in adjacent areas, causing a risk of thermal damage if the treatment light diffuses to the adjacent blood rich zone. It is well known to light-based hair removal practitioners that acute pain is felt during the treatment when hairy areas, particularly characterized by dark thick hair, are impinged by the treatment beam, whereas firing the light beam on a hairless area is substantially painless. It can therefore be concluded that the pain which is sensed during a hair removal treatment is generated by nerves surrounding the hair shafts, and not by nerves distributed in other areas of the skin. There is therefore a need for an improved apparatus for pain reduction without having to reduce the treatment energy density.
According to the Gate Theory of Afferent Inhibition described in, for example, “The Physiology Coloring Book,” W. Kapit et al, Harper Collins Publishers (1987), pages 88-89, the pressure sensed by large, fast-conducting tactile nerves, such as by rubbing the skin, limits the transmission gates in the dorsal horn, excludes access for the weaker pain signal, and therefore inhibits the pain signal transmission by pain nerves in the spinal cord. During light-based skin treatments, pain nerves in the vicinity of the epidermis and adjacent to hair follicles sense a relatively high increase in temperature of the hair follicle, often greater than 70° C. If not inhibited, the pain nerves transmit a pain signal to the brain via the spinal cord. Due to sensed pain, the treatment time is considerably increased.
Two types of a pain sensation caused by light-based aesthetic treatments are recognizable: immediate sharp pain and long term milder pain. The immediate sharp pain is felt during each treatment pulse and increases to an intolerable sensation after a few shots, necessitating a patient to rest during a long delay before continuing the treatment. The treatment rate, particularly for large areas such as on the legs, is therefore considerably reduced. Depending on his pain tolerance, the patient may even decide not to continue the treatment. The sharp pain is caused by the exposure of treatment light to nerve endings located in the epidermis and dermis, by sensory receptors of hair shafts located deep in the dermis, or by the stimulation of nerves surrounding the hair bulbs as the hair shafts are being heated during the treatment, often at a temperature of approximately 70° C.
The less acute, long term milder pain is caused by the accumulative increase of skin temperature following treatment, e.g. during a period ranging from 10 minutes to a day after treatment, which is approximately 3 to 5° C. above body temperature. The increase in skin temperature may induce redness and edema, causing pain, depending on the hair density and the fractional blood volume within the adjoining tissue. The application of a cold gauze immediately after the treatment usually helps to avoid the post-treatment pain.
The most common prior art method for alleviating or preventing the immediate sharp pain caused by the non-ablative treatment of hair or of vascular lesions with intense pulsed light is the application of EMLA cream produced by AstraZeneca Canada Inc. Such cream is a topical anesthetic applied to the skin approximately 30-60 minutes before a treatment, which numbs the skin and decreases the sensation of pain. This prior art method is generally impractical due to the long and inconvenient waiting time between the application of the EMLA cream and the treatment. Since health professionals prefer to maximize the number of patients to be treated during a given time period, the health clinic must provide a large waiting room for those patients that are waiting to be treated by intense pulsed light following the application of the EMLA cream.
Pain caused by the non-ablative treatment of hair or of vascular lesions may also be alleviated or prevented by reducing the energy density of the intense pulsed light. Energy density reduction, however, compromises the treatment quality, and therefore is an unacceptable solution, particularly due the relatively high cost of treatment.
U.S. Pat. Nos. 6,264,649 and 6,530,920 disclose a cooling head for a skin treatment laser and a method to reduce or eliminate pain during laser ablative treatments of the skin by cooling the skin surrounding the treatment area. The pain is associated with the ablation or burning of a skin surface during skin resurfacing. An extraction port of the cooling head enables removal of debris material, such as smoke produced by the skin treatment laser, from the treatment area and for connection to a vacuum source. Evacuated vapor such as smoke is replaced by fresh and clean air.
With respect to prior art smoke evacuation devices, a significant subatmospheric pressure is generally not generated over a skin surface due to the introduction of fresh atmospheric pressure air. If subatmospheric pressure were maintained over a skin surface, the treatment handpiece would be prevented from being lifted and displaced from one skin site to another during the treatment process. Additionally, prior art smoke evacuation devices are not associated with non-ablative lasers, such as a long-pulse Nd:YAG laser, which treat tissue only under the skin surface and do not produce smoke resulting from the vaporization of the skin surface. Furthermore, the application of heat releasing gel onto a skin target is not conducive for the ablation of a skin surface or for the subsequent evacuation of debris material since the gel forms a barrier between the skin surface and the surrounding air.
Current laser and IPL skin treatment systems utilize chilling means. However, pain is still noticeable.
A need therefore exists for alleviating the resulting pain caused by the treatment of unwanted hair, unwanted wrinkles or vascular lesions by intense pulsed light or intense pulsed laser systems, without reducing the light source intensity, without applying a topical anesthetic, and without using a chiller as means to reduce pain.
It is an object of the present invention to provide a method and apparatus for the treatment of subcutaneous lesions, such as vascular lesions, by a non-ablative, high intensity pulsed laser or light system operating at wavelengths shorter than 1800 nm which does not damage the surface of the skin or the epidermis.
It is an object of the present invention to provide a method and apparatus for controlling the depth of subcutaneous light absorption.
It is an object of the present invention to provide a method and apparatus for increasing the absorption of light which impinges a skin target by increasing the concentration of blood vessels thereat.
It is an additional object of the present invention to provide a method and apparatus by which the energy density level of intense pulsed light that is suitable for hair removal, fine wrinkle removal, including removal of wrinkles around the eyes and in the vicinity of the hands or the neck, and the treatment of port wine stain or rosacea may be reduced relative to that of the prior art.
It is an additional object of the present invention to provide a method and apparatus by which the number of required treatments for hair removal, fine wrinkle removal, including removal of wrinkles around the eyes and in the vicinity of the hands or the neck, and the treatment of port wine stain or rosacea at currently used energy density levels may be reduced relative to that of the prior art.
It is yet an additional object of the present invention to provide a method and apparatus for repeated evacuation, prior to the firing of a subsequent light pulse, of vapors which condense on the distal window due to the chilling of laser treated skin.
It is yet an additional object of the present invention to provide a method and apparatus for alleviating the resulting pain caused by the treatment of unwanted hair, unwanted wrinkles or vascular lesions by intense pulsed light or intense pulsed laser systems, without reducing the light source intensity, without applying a topical anesthetic, and without relying on skin chilling for pain reduction.
It is yet an additional object of the present invention to provide a method and apparatus for speedy repositioning of a vacuum-assisted, non-ablative light-based treatment handpiece from one site to another.
It is yet an additional object of the present invention to provide a method and apparatus for a vacuum-assisted, light-based skin treatment which is conducive for the application of a heat releasing gel onto a skin surface, without resulting in obstruction of vacuum generating apparatus.
It is a further object of the present invention to provide an apparatus for vacuum-assisted, light-based treatment which can be held by one hand while a light treatment handpiece is held by the other hand.
Other objects and advantages of the invention will become apparent as the description proceeds.
The present invention is directed to apparatus for vacuum-assisted light-based skin treatments. The apparatus comprises a vacuum chamber which is transparent or translucent to intense pulsed monochromatic or non-coherent light directed to a skin target. A vacuum is applied to said vacuum chamber, whereby said skin target is drawn to said vacuum chamber. The efficacy and utility of the apparatus are achieved by employing the apparatus in two modes: (a) in a vacuum applying mode wherein a high vacuum level ranging from 0-1 atmospheres is attained and (b) in a vacuum release mode upon deactivation of the light source and of the vacuum pump after optical energy associated with the directed light has been absorbed within a predetermined depth under the skin surface, wherein atmospheric air is introduced to the vacuum chamber so that the vacuum chamber may be speedily repositioned to another skin target.
In one embodiment of the invention, the apparatus comprises:
As referred to herein, “distal” is defined as a direction towards the exit of the light source and “proximate” is defined as a direction opposite from a distal direction.
As referred to herein, the term “transmitting element” includes an element through which electromagnetic energy suitable for effecting a desired treatment is transmitted to a selected skin target. When the electromagnetic energy is light, the transmitting element is an optical element. When the electromagnetic energy is RF energy, the transmitting element may be metallic.
The terms “evacuation chamber” and “vacuum chamber” as referred to herein are interchangeable.
As referred to herein, a “vacuum level” is the absolute pressure below atmospheric pressure. A vacuum level of 500 mmHg is therefore a pressure of 500 mmHg below atmospheric pressure. When a vacuum level is referred to as being greater than a given value, e.g. greater than 400 mmHg, the pressure therein is an absolute pressure of a value below atmospheric pressure greater than said given value.
The vacuum chamber is advantageously one-hand graspable by means of a handle connected thereto so that the vacuum chamber can be held by one hand while a light treatment handpiece is held by the other hand.
Preferably, the apparatus further comprises control means for controlling operation of the vacuum pump, the at least one control valve, and the light source. The control means is selected from the group of electronic means, pneumatic means, electrical means, and optical means. The control means may be actuated by means of a finger depressable button, which is positioned on a light treatment handpiece.
In one aspect, the control means is suitable for firing the light source after a first predetermined delay, e.g. from approximately 0.5 sec to approximately 4 seconds, following operation of the vacuum pump.
In one aspect, the control means is suitable for firing the light source after a predetermined delay following opening of the at least one control valve.
In one aspect, the control means is suitable for increasing the pressure in the vacuum chamber to atmospheric pressure following deactivation of the light source, to allow for effortless repositioning of the vacuum chamber to a second skin target. The increase in vacuum chamber pressure may be triggered by means of a light detector which transmits a signal to the control means upon sensing a significant decrease in optical energy generated by the light source or may be effected after a second predetermined delay, following deactivation of the light source.
In one aspect, the control means is suitable for verifying that a desired energy density level of the light is being directed to the skin target and for deactivating the light source if the energy density level is significantly larger than said desired level.
In one aspect, the vacuum chamber is connected to, or integrally formed with, a proximately disposed handpiece through which light propagates towards the skin target. The vacuum chamber has a proximate cover formed with an aperture, said cover being attachable or releasably attachable to a handpiece such as a light guide having an integral transmitting element.
In one aspect, the vacuum pump is an air pump.
In one aspect, the vacuum pump is a pump, e.g. a peristaltic pump, for drawing air and gel from the interior of the vacuum chamber via a hose connected to a conduit in communication with the interior of the vacuum chamber. The hose provides indication means that the skin target has undergone a light-based treatment by means of gel which is discharged from an end of the hose onto a skin surface during a vacuum applying mode.
In one aspect, the apparatus further comprises means to stabilize the vacuum chamber on a substantially non-planar skin surface.
In one aspect, the apparatus further comprises a skin contact detector for sensing the placement of the vacuum chamber onto the skin target and for generating a first signal to activate the vacuum pump following placement of the vacuum chamber onto the skin target.
In one aspect, the control valve is opened following generation of a second signal by means of a light detector which is adapted to sense termination of the light directed to the skin target, atmospheric pressure air thereby being introduced to the interior of the vacuum chamber.
In one aspect, the second signal is suitable for deactivating the vacuum pump.
In another embodiment of the invention, the apparatus further comprises an array of vacuum chambers placeable on a skin surface. The array is formed from a single sheet made of material which is transparent or translucent to the light, said sheet being formed with a plurality of conduits for air evacuation such that each of said conduits is in communication with a corresponding vacuum chamber. The distance between adjacent vacuum chambers is sufficiently small to allow light which has diffused from the interior of each chamber to treat a skin area located underneath a corresponding conduit.
Each conduit preferably branches into first and second portions which are in communication with a vacuum pump and with a source of compressed air, respectively.
In one aspect, each vacuum chamber is provided with a contact detector for triggering a signal to activate the vacuum pump, two control valves to control the passage of fluid through the corresponding first and second conduits portions, respectively, and a light detector which generates a signal to introduce compressed air through the corresponding second conduit portion upon sensing the termination of the light directed to the skin target.
In one aspect, the first conduit portions are arranged such that the air from all vacuum chambers is evacuated simultaneously upon activation of the vacuum pump.
In another embodiment of the invention, the vacuum applying means comprises a vertically displaceable cover to which the transmitting element is secured and chamber walls which surround, and are of a similar shape as, said cover, a vacuum being generated within a vacuum chamber defined by the volume between said cover, said walls, and the skin target upon proximal displacement of said cover relative to said walls. The means for preventing influx into the vacuum chamber is a sealing element which is secured to the outer periphery of the cover and resiliently contacts the chamber walls.
In one aspect, a proximally directed force or distally directed force is generated by any means selected from the group of a plurality of solenoids, a spring assembly, and a pneumatic device, or a combination thereof, which are deployed around the periphery of the cover and connected to the walls, and is controllable so as to adjust the height of the drawn skin target relative to the adjoining skin surface. Due to their low power consumption, a 1.5 V battery may be used to energize the solenoids.
The apparatus preferably further comprises an aeration tube for introducing atmospheric air to the vacuum chamber during a vacuum release mode. The aeration tube is in communication with a valve which is actuated upon conclusion of a skin target treatment.
In one aspect, the proximally directed force is supplemented by means of a vacuum pump.
In another embodiment of the invention, the apparatus comprises means for preventing passage of skin cooling gel to the vacuum applying means.
In one aspect, the means for preventing passage of gel to the vacuum applying means comprises a trap, a first conduit through which gel and air are drawn from the vacuum chamber to said trap, a second conduit through which air is drawn from said trap to the vacuum pump, and optionally, a filter at the inlet of the first and second conduits.
In one aspect, the trap is suitable for the introduction therein of an ion exchange resin with which the gel is boundable.
In one aspect, the means for preventing passage of gel is a detachable vacuum chamber upper portion, detachment of said upper portion allowing removal of gel retained within the vacuum chamber interior. Suitable apparatus comprises an upper portion having an open central area, a transmitting element attached to said upper portion, vacuum chamber walls, a vacuum chamber cover perpendicular to said walls and suitably sized so as to support said upper portion, and a plurality of attachment clips pivotally connected to a corresponding vacuum chamber wall for detachably securing said upper portion to said vacuum chamber cover.
In one aspect, the vacuum chamber walls are coated with a hydrophobic material. Accordingly, the vacuum chamber provides indication that the skin target has undergone a light-based treatment by means of gel which falls to the skin surface during a vacuum release mode in the shape of the distal end of the vacuum chamber walls.
In one aspect, the at least one suction opening is sufficiently spaced above the distal end of a vacuum chamber wall and from the centerline of the vacuum chamber so as to prevent obstruction of the at least one suction opening by gel and drawn skin upon application of the vacuum.
In another embodiment of the invention, the apparatus further comprises means for skin cooling, said skin cooling means adapted to reduce the rate of temperature increase of the epidermis at the skin target. The level of the applied vacuum is suitable for evacuating condensed vapors which are produced within the gap between the transmitting element and the skin target and condense on the transmitting element during the cooling of skin.
In one aspect, the skin cooling means is a metallic plate in abutment with the vacuum chamber on the external side thereof, said plate being cooled by means of a thermoelectric cooler. The plate may be positionable on the skin surface adjoining said skin target in order to cool the lateral sides of the vacuum chamber or may be in contact with the transmitting element.
In one aspect, the skin cooling means is a polycarbonate layer transparent to the directed light which is attached to the distal face of the transmitting element.
In one aspect, the skin cooling means is a gel, a low temperature liquid or gas applied onto the skin target.
In another embodiment of the invention, the apparatus is suitable for controlling the depth of light absorption by blood vessels under a skin surface, comprising:
As referred to herein, the term “blood volume fraction” is interchangeable with “the concentration of blood and/or blood vessels within a predetermined depth below the skin surface”.
In one embodiment, the means for inducing an increase in the concentration of blood and/or blood vessels within a predetermined depth below the skin surface of said skin target is a means for modulating the applied vacuum.
The depth under the skin surface at which optical energy is absorbed may be selected in order to thermally injure or treat predetermined skin structures located at said depth. As referred to herein, a “skin structure” is defined as any damaged or healthy functional volume of material located under the epidermis, such as blood vessels, collagen bundles, hair shafts, hair follicles, sebacious glands, sweat glands, adipose tissue. Depending on the blood concentration within the skin target, the light may propagate through the skin surface and upper skin layers without being absorbed thereat and then being absorbed at a skin layer corresponding to that of a predetermined skin structure. As referred to herein, the term “light” means both monochromatic and non-coherent light. The terms “light absorption” and “optical energy absorption” refer to the same physical process and are therefore interchangeable.
In contrast with a prior art vacuum-assisted apparatus for laser or intense pulsed light treatment wherein a sharp skin fold is produced through a slit following application of the vacuum, vacuum-assisted drawn skin by means of the apparatus of the present invention is not distorted, but rather is slightly and substantially uniformly drawn to the vacuum chamber, protruding approximately 1-2 mm from the adjoining skin surface. The maximum protrusion of the drawn skin from the adjoining skin surface is limited by a transmitting element defining the proximate end of the vacuum chamber. The transmitting element is separated from the adjoining skin surface by a gap of preferably 2 mm, and ranging from 0.5-50 mm. In one embodiment of the invention, the drawn skin abuts the transmitting element.
As referred to herein, “vacuum modulation” means adjustment of the vacuum level within, or of the frequency by which vacuum is applied to, the vacuum chamber. By properly modulating the vacuum, the blood flow rate, in a direction towards the vacuum chamber, within blood vessels at a predetermined depth below the skin surface can be controlled. As the concentration of blood and/or blood vessels is increased within the skin target, the number of light absorbing chromophores is correspondingly increased at the predetermined depth. The value of optical energy absorbence at the predetermined depth, which directly influences the efficacy of the treatment for skin disorders, is therefore increased.
In one embodiment of the invention, the means for inducing an increase in the concentration of blood and/or blood vessels within a predetermined depth below the skin surface of said skin target is at least one support element positioned at a skin area adjoining the skin target and having a thickness suitable for inducing an increase in the concentration of blood and/or blood vessels within said predetermined depth. The apparatus may further comprise at least one leg having a thickness considerably less than the at least one support element and positioned at the periphery of the vacuum chamber, said at least one leg being separated from an adjacent support element, the at least one support element being adapted to urge blood expelled by said at least one leg towards the skin target.
The predetermined depth under the skin surface at which optical energy is absorbed is selected in order to thermally injure or treat predetermined skin structures located at said depth.
Due to implementation of the apparatus, the treatment energy density level for various types of treatment is significantly reduced, on the average of 50% with respect with that associated with prior art devices. The treatment energy density level is defined herein as the minimum energy density level which creates a desired change in the skin structure, such as coagulation of a blood vessel, denaturation of a collagen bundle, destruction of cells in a gland, destruction of cells in a hair follicle, destruction of unwanted lesions by means of photodynamic therapy, or any other desired effects. The following is the treatment energy density level for various types of treatment performed with use of the present invention:
The preferably further comprises a control unit for controlling operation of the vacuum applying means and light source. The control unit is also suitable for controlling operation of at least one control valve in communication with the vacuum chamber, for firing the light after a predetermined delay following application of the vacuum, and for electronically modulating the vacuum.
In one aspect, the apparatus further comprises a skin contact detector for sensing the placement of the vacuum chamber onto the skin target, the control unit being suitable for activating the vacuum applying means in response to a signal transmitted by said skin contact detector.
In one aspect, the apparatus further comprises a light detector for sensing the termination of the light directed to the skin target, the control unit being suitable for regulating a control valve in response to a signal transmitted by said light detector so as to introduce atmospheric pressure air to the interior of the vacuum chamber.
In one aspect, the apparatus further comprises a pulsed radio frequency (RF) source for directing suitable electromagnetic waves to the skin target. The frequency of the electromagnetic waves ranges from 0.2-10 MHz. The RF source is either a bipolar RF generator which generates alternating voltage applied to the skin surface via wires and electrodes or a monopolar RF generator with a separate ground electrode. The control unit is suitable for transmitting a first command pulse to the at least one control valve and a second command pulse to both the intense pulsed light source and RF source.
In one aspect, the apparatus further comprises an erythema sensor, said sensor suitable for measuring the degree of skin redness induced by the vacuum applying means. The control unit is suitable for controlling, prior to firing the light source, the energy density of the light emitted from the light source, in response to the output of the erythema sensor.
In one aspect, the vacuum chamber has a proximate cover formed with an aperture, said cover being attachable to a handpiece, such as a light guide, having an integral transmitting element.
In one aspect, the apparatus further comprises means for skin cooling, said skin cooling means adapted to reduce the rate of temperature increase of the epidermis at the skin target.
In one aspect, the apparatus further comprises means for preventing passage of skin cooling gel to the vacuum applying means.
In another embodiment of the invention, the apparatus is suitable for alleviating or preventing pain caused by a non-ablative light-based treatment of a targeted skin structure. Accordingly, the gap separating said the transmitting element from the skin surface adjoining said the skin target and the magnitude of the proximally directed force resulting from said the applied vacuum in combination are suitable for drawing said the skin target to said the vacuum chamber via the opening on the distal end of the vacuum chamber said aperture until said the skin target contacts said the transmitting element; and the control means is suitable for firing the light source after the first predetermined delay, following operation of the vacuum applying means.
In one aspect, the apparatus is suitable for causing the skin target to contact the transmitting element for a duration equal to, or greater than, the first predetermined delay, whereby pain signals generated by the nervous system during the treatment of the skin structure are alleviated or prevented.
The control means is preferably suitable for controlling the vacuum level generated by the vacuum applying means, and has a plurality of finger depressable buttons, each of which being adapted to set the vacuum applying means and light source at a unique combination of operating conditions so as to generate a predetermined vacuum level within the vacuum chamber and to fire the light source after a predetermined time delay following the operation of the vacuum applying means.
In one aspect, a single light source and vacuum pump are operable in conjunction with differently configured vacuum chambers, for example a vacuum chamber that is suitable for pain alleviation or a vacuum chamber that is suitable for inducing an increase in blood concentration within a skin target. Each differently configured vacuum chamber is releasably attachable to a treatment light handpiece, e.g. by means of suitable threading or clips.
In another embodiment of the invention, a dermatological vacuum pump is provided which is in fluid communication with a vacuum chamber placeable on a gel coated skin area and provided with a transmitting element transparent or translucent to pulsed light suitable for effecting a light-based dermatological treatment on the proximate end thereof and with an opening on the distal end thereof.
The pump comprises an eccentrically rotating rotor having an outer profile of generally equilateral triangular shape with convexly curved faces terminating at an apex, wherein each of said faces is formed with a central face slot adjacent to the centerline of the corresponding face and substantially parallel thereto; and a casing formed with an epitrochoidal inner wall defining a cavity in which said rotor rotates and being configured such that the apexes of said rotor are in contact with said wall throughout the eccentric angular displacement of said rotor.
Variably sized compartments defined by the volume within said cavity between said inner wall and a corresponding face of said rotor and through which controlled volumes of air and gel drawn from said vacuum chamber are sequentially transferable to a pump discharge, following operation of said pump, are established. Each of said compartments increases from a first volume to a second volume in an intake-expansion cycle to generate a vacuum in said vacuum chamber, decreases from said second volume to a third volume in a compression-exhaust cycle to discharge air and gel. A corresponding rotor face in the vicinity of a central face slot is flexible upon reaction to the force applied thereto by gel that is pressurized within a corresponding compartment during a compression-exhaust cycle.
The pump is capable of simultaneously evacuating both gel and air from the vacuum chamber, despite the very high pressure generated within the pump by the incompressible gel. The pump is also capable of evacuating any other liquid having slight or considerable viscosity from the vacuum chamber, when such a viscous liquid is used to conduct heat from a skin area during a light-based treatment. When the term “gel” is referred to hereinafter, a viscous liquid will be included by reference as well.
The casing is formed with an inlet in communication with a conduit through which air and gel are drawn from the interior of the vacuum chamber to the pump cavity and with an outlet through which the air and gel are discharged to an exhaust tube. The pump preferably further comprises an exhaust pipe larger in size than the exhaust tube.
The vacuum pump preferably further comprises means for restoring the pressure within the vacuum chamber to atmospheric pressure, e.g. within approximately 0.1 second. The vacuum chamber pressure is restored to atmospheric pressure by reversing the rotational direction of the pump, in order to deliver atmospheric-pressure air to the vacuum chamber.
The vacuum pump is preferably capable of evacuating air and gel from said vacuum chamber for at least 500 treatment cycles, each of said treatment cycles being characterized by a vacuum generating step, a treatment firing step, and a vacuum release step, and of generating, during each of said treatment cycles, a vacuum level within said vacuum chamber which is suitable for drawing said skin area to said vacuum chamber via said opening.
The vacuum level generated within the vacuum chamber is preferably greater than 500 mm Hg. The evacuation rate of the vacuum pump is sufficiently high to allow the completion of a treatment cycle at each treatment site within 3 seconds, and preferably 1-3 seconds, 2-3 seconds, or even less than one second.
The vacuum pump preferably further comprises means for limiting the vacuum level generated within the vacuum chamber. The vacuum level generated within the vacuum chamber is limited by means of remaining atmospheric-pressure not discharged through the exhaust tube or exhaust pipe, said remaining atmospheric-pressure air being transferable to the inlet and mixable with the air drawn from the vacuum chamber. The vacuum level generated within the vacuum chamber is limited to approximately 0.05-0.1 atmospheres.
The vacuum pump preferably further comprises means for the rotor to conform to the shape of the casing. Such means comprises an end face slot formed in each rotor face in the vicinity of a corresponding apex. Each of the end face slots is substantially perpendicular to the corresponding face and divides the same into a relatively small portion and a relatively long portion such that said relatively small portion is flexible upon contact of a corresponding apex with a first region of the inner casing wall whereat the gap of the rotor cavity is of a different dimension than at a second region of the inner casing wall.
The power consumption of a motor adapted to drive a shaft on which the rotor is mounted preferably ranges from approximately 1 to 10 W.
The vacuum pump preferably further comprises a pump cover and bottom which remain essentially in sealing abutment with the casing throughout each treatment cycle.
The rotor, casing, cover and bottom are preferably made from a self-lubricating material such as polymeric material, e.g. a mixture of approximately 70% Acetal and approximately 30% Teflon which has a coefficient of friction of approximately 0.05.
In one aspect, the rotor, casing, cover and bottom are made of steel.
The vacuum pump preferably further comprises a sealing ring surrounding the top and bottom covers and a sealing disc interposed between each of the top and bottom covers.
The pump volume is preferably no greater than 25 cm3 and therefore the conduit has a length of no greater than 10 cm.
The present invention is also directed to a dermatological handpiece system, comprising:
In one aspect, the control unit, following reception of a suitable command, is capable of reversing the rotational direction of the motor and consequently of the rotor, in order to deliver atmospheric-pressure air to the vacuum chamber.
In one aspect, gel discharged from the exhaust tube to a skin area constitutes indication means that a skin target has undergone a light-based treatment.
In one aspect, the means for activating and deactivating the motor are at least one sensor in electrical communication with the control unit.
In one aspect, the handpiece body has a sufficiently small size, low weight and ergonometric design so as to prevent operator fatigue when intermittently held by one hand of an operator for more than one hour during repeated repositioning thereof to different skin areas.
In one embodiment, the handpiece body further houses the light source. Accordingly, the control unit is adapted to control the operation of both the vacuum pump and of the light source, and is therefore suitable for synchronizing in sequence a vacuum generating step, a treatment firing step, and a vacuum release step for each treatment cycle of a corresponding skin area.
The control unit is suitable for synchronizing a predetermined delay ranging from approximately 0.5 sec to approximately 4 seconds between the activation of the vacuum pump and the firing of the source, in order to ensure that a drawn skin area will be in contact with the clear transmitting element of the vacuum chamber for a sufficiently long nerve inhibiting duration after the light source is fired.
The control unit is also suitable for increasing the pressure in the vacuum chamber to atmospheric pressure by reversing the polarity of the motor following deactivation of the light source.
In one embodiment, an apparatus for alleviating or preventing pain caused by a treatment with electromagnetic energy of a targeted skin structure comprises:
In one embodiment, an apparatus for alleviating or preventing pain caused by a light-based treatment of a targeted skin structure comprises:
In one aspect, the apparatus further comprises gliding apparatus for displacing a light source distal end over the transmitting element at a speed ranging from 0.3 to 40 cm/sec.
In one aspect, the apparatus further comprises a scanner for scanning by means of said generated light substantially the entire area of the skin target which underlies the transmitting element at a repetition rate of up to 5 pulses/sec.
In one aspect, the apparatus further comprises a pressure sensor in communication with the interior of the vacuum chamber for determining whether the applied vacuum level is sufficient to inhibit the transmission of pain signals.
In one aspect, the apparatus further comprises a skin contact detector for sensing the placement of the vacuum chamber onto the skin target.
In one aspect, the apparatus is suitable for evacuating air and gel from the vacuum chamber.
In one aspect, the vacuum pump is a rotary pump, such as one that has an eccentrically rotating rotor having an outer profile of generally equilateral triangular shape with convexly curved faces terminating at an apex, each of said faces being formed with a central face slot adjacent to the centerline of the corresponding face and substantially parallel thereto.
In one aspect, the transmitting element is chilled.
In one aspect, the apparatus further comprises means for centering a light source distal end with respect to, and above, walls of the vacuum chamber.
In one aspect, the apparatus further comprises means for repositioning the vacuum chamber to another skin target without gaps or overlaps.
In one aspect, the apparatus further comprises an electronic control unit which is suitable for:
In one aspect, the apparatus further comprises a dissolving solution pump in fluid communication with a dissolving solution reservoir and with a conduit connected to a vacuum pump discharge, for cleaning and dissolving accumulated gel. Accordingly, the control unit is further adapted to transmit a seventh signal to a dissolving solution pump actuator to activate the dissolving solution pump following a predetermined number of cycles of the vacuum applying and vacuum release mode.
In one embodiment, a method of painless hair removal comprises the steps of:
In one embodiment, a method for the painless removal of tattoos or of pigmented lesions comprises the steps of:
In one embodiment, a method for alleviating or preventing pain caused by a non-ablative light-based treatment of a targeted skin structure comprises:
In one aspect, the step of directing the distal end of the light source to another skin target is performed by gliding the light source distal end over the transmitting element.
In one aspect, the step of directing the distal end of the light source to another skin target is performed by means of a scanner.
In one aspect, the delay ranges from approximately 0.5 sec to approximately 4 seconds.
In one aspect, the light source is an intense pulsed monochromatic or non-coherent light source.
In one aspect, the light is in any optical band in the spectral range of 400 to 1800 nm.
In one aspect, the desired treatment is selected from the group of hair removal, treatment of vascular lesions, collagen contraction, tattoo removal, and treatment of pigmented lesions.
In one aspect, the vacuum level ranges from approximately 0 to 1 atmosphere.
In one aspect, the duration of the applied vacuum ranges from 0.1 to 6 seconds.
In one embodiment, an apparatus for the treatment of skin disorders comprises:
In one embodiment, an apparatus for the treatment of skin disorders comprises:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
In the drawings:
The present invention is directed to apparatus which is provided with a unit for evacuating vapors, such as condensed vapors that were produced during the chilling of skin prior to the firing of the laser unit. The evacuation unit comprises a U-shaped vacuum chamber through which monochromatic or intense pulsed light passes as it is directed to a skin target, and a vacuum pump. During operation of the vacuum pump, the vacuum level within the vacuum chamber is increased by occluding a conduit of the vacuum chamber e.g. by a finger of the operator. As vacuum is applied to the skin target, skin is drawn toward the vacuum chamber and the concentration of blood vessels in the vicinity of the target increases. The added concentration of blood vessels increases the absorption of light within the tissue, and therefore facilitates treatment of a skin disorder.
In some cellulite massage devices, such as those produced by Deka (Italy) or the Lumicell Touch (USA), a low power continuous working infrared light source with a power level of 0.1-2 W/cm2 provides deep heating of the cellulite area and additional stimulation of lymphatic flow. Such a light source is incapable of varying the temperature by more than 2-3° C., since higher temperatures would be injurious to the tissue and cause hyperthermia. Consequently these massage devices are unable to attain the temperatures necessary for achieving selective thermal injury of blood vessels, hair follicles or for the smoothening of fine wrinkles. Due to the movement of the device, the amount of optical energy, e.g. by means of an optical meter, to be applied to the skin cannot be accurately determined.
Although the application of a vacuum to a skin surface has been employed in the prior art to supplement skin treatments performed by means of optical energy, many significant differences between prior art apparatus for a vacuum-assisted light-based skin treatment to that of the present invention are evident:
The direction of blood transfer is dependent on the ratio of the skin target diameter to the thickness of the vacuum chamber walls. In
Apparatus for Controlling Depth of Light Absorption
Evacuation unit 1090 comprises vacuum pump 1080, vacuum chamber C, and conduits 1078 and 1079 in communication with chamber C. Vacuum chamber C, which is placed on skin surface 1075, is formed with an aperture (not shown) on its distal end and is provided with a transmitting element 1076 on its proximate end. Vacuum chamber C is integrally formed with handpiece 1073, such that cylindrical wall 1091 is common to both handpiece 1074 and vacuum chamber C. Element 1076 is transparent to beam 1074 of intense pulsed monochromatic or non-coherent light which is directed to skin target T. Element 1076 is positioned such that beam 1074 is transmitted in a direction substantially normal to skin surface 1075 adjoining skin target T. The ratio of the maximum length to maximum width of the aperture, which may be square, rectangular, circular, or any other desired shape, ranges from approximately 1 to 4. Since the aperture is formed with such a ratio, skin target T is proximately drawn, e.g. 1 mm from skin surface 1075, and is slightly deformed, as indicated by numeral 1087, while increasing the concentration of blood in skin target T. Likewise, employment of an aperture with such a ratio precludes formation of a vacuum-induced skin fold, which has been achieved heretofore in the prior art and which would reduce the concentration of blood in skin target T.
Wall 1091 is formed with openings 1077 and 1084 in communication with conduits 1078 and 1079, respectively. The two conduits have a horizontal portion adjacent to the corresponding opening, a vertical portion, and a long discharge portion. Openings 1077 and 1084 are sealed with a corresponding sealing element 1093, to prevent seepage of fluid from the vacuum chamber. Conduit 1079 is also in communication with vacuum pump 1080, which draws fluid, e.g. air, thereto at subatmospheric pressures. U-shaped vacuum chamber C is therefore defined by transmitting element 1076 of the handpiece, slightly deformed skin surface 1087, wall 1091 and conduits 1078 and 1079.
A suitable light source is a pulsed dye laser unit, e.g. produced by Candela or Cynosure, for the treatment of vascular lesions, which emits light having a wavelength of approximately 585 nm, a pulse duration of approximately 0.5 microseconds and an energy density level of 10 J/cm2. Similarly any other suitable high intensity pulsed laser unit, such as a Nd:YAG, pulsed diode, Alexandrite, Ruby or frequency doubled laser, operating in the visible or near infrared region of the spectrum may be employed. Similarly, a laser unit generating trains of pulses, such as the Cynosure Alexandrite laser, the Lumenis “Quatim” IPL or Deka “Silkapill”. The emitted light is transmitted via optical fiber 1072 to handpiece 1073. Handpiece 1073 is positioned such that transmitting element 1076 faces skin surface 1087. Beam 1074 propagating towards slightly protruded skin surface 1087 is substantially normal to skin surface 1075.
Following operation of vacuum pump 1080, air begins to become evacuated from vacuum chamber C via conduit 1079. Occluding conduit 1078, such as by placing finger 1083 of an operator on its outer opening increases the level of the vacuum within chamber C to a pressure ranging from 200 to 1000 millibar. The application of such a vacuum slightly draws skin target T towards chamber C without being pressed, as has been practiced heretofore in the prior art, thereby increased the concentration of blood vessels within skin target T. The efficacy of a laser unit in terms of treatment of vascular lesions is generally greater than that of the prior art, due to the larger concentration of blood vessels in skin target T, resulting in greater absorption of the optical energy of beam 1074 within bodily tissue.
The operator may fire the laser following application of the vacuum and the subsequent change in color of skin target T to a reddish hue, which indicates that the skin is rich in blood vessels. The time delay between the application of the vacuum and the firing of the laser is based on clinical experience or on visual inspection of the tissue color.
Apparatus 1170 comprises handpiece 1101, laser system 1116, evacuation unit 1190 and control unit 1119.
Laser system 1116 includes a power supply (not shown), a light generation unit (not shown), and power or energy detector 1130 for verifying that the predetermined energy density value is applied to the skin target. Handpiece 1101 held by the hand of the operator is provided with lens 1104, which directs monochromatic beam 1105 transmitted by optical fiber 1103 from laser system 1116 to skin target area 1140. Transmitting element 1100 defining vacuum chamber 1106 is generally in close proximity to skin surface 1142, at a typical separation H of 1-2 mm and ranging from 0.5 to 4 mm, depending on the diameter of the handpiece. The separation is sufficiently large to allow for the generation of a vacuum within chamber 1106, but less than approximately one-half the diameter of the window 1100, in order to limit the protrusion of skin target 1140 from the adjoining skin surface 1142. By limiting the separation of element 1100 from skin surface 1142 while maintaining the vacuum applied to skin target 1140, formation of a skin fold is precluded while more blood may be accumulated in a smaller skin thickness. Therefore a significant local rise in the temperature of a blood vessel, which ranges from 50-70° C., is made possible.
Evacuation unit 1190 comprises vacuum chamber 1106 which is not U-shaped, miniature vacuum pump 1109 suitable for producing a vacuum ranging from 200-1000 millibar, conduit 1107 and control valve 1111 through which subatmospheric fluid is discharged from chamber 1106, and miniature pressurized tank 1110 containing, e.g. 100 ml, which delivers air through conduit 1112 and control valve 1108 to chamber 1106. If so desired, a transmitting element need not be used, and vacuum chamber 1106 defined by lens 1104 will have an accordingly larger volume.
Control unit 1119 comprises the following essential elements:
Tank 1110, in which air having a pressure ranging from 1-2 atmospheres is contained, provides a fast delivery of less than 1 msec of air into chamber 1106, as well as a correspondingly fast regulation of the vacuum level therein by first opening control valves 1108 and 1111 and activating vacuum pump 1109. After a sufficient volume of fluid, e.g. 1 ml, is delivered to chamber 1106, control valve 1108 is closed. Control circuitry 1126 and 1143 then regulate the operation of the control valves so to maintain a predetermined level of vacuum. Upon achieving the predetermined vacuum level, control circuitry 1123 fires laser system 1116 after the predetermined time delay, which may range from 1-1000 msec.
Control unit 1119 may also be adapted to increase the pressure in vacuum chamber 1106 to atmospheric pressure (hereinafter in “a vacuum release mode”) following deactivation of the pulsed light beam source, to allow for effortless repositioning of the vacuum chamber to another skin target. In order to achieve a fast response time between the deactivation of the light source and the pressure increase within the vacuum chamber prior to repositioning the vacuum chamber to another skin target, light detector 1185 is employed to detect the light emitted by the treatment light source. When the light detector ceases to detect light emitted by the light source, a suitable command is transmitted to control unit 1119, whereupon the latter generates a command to open control valve 1111, in order to increase the vacuum chamber pressure. Alternatively, the vacuum within the vacuum chamber may be released by depressing a pneumatically or electrically actuated button located on the handpiece, following deactivation of the light source. Employment of a light detector which triggers the release of the vacuum in the vacuum chamber in order to allow for the speedy repositioning of the treatment handpiece has particular significance in conjunction with fast treatment systems such as the hair removal “Light Sheer” diode system produced by Lumenis, which operates at a fast rate of 1 pulse per second.
It will be appreciated that the utilization of a U-shaped vacuum chamber 1306 for the evacuation of vapors which condense on transmitting element 1376 is particularly advantageous when a skin chiller in permanent contact with the handpiece outer wall is employed. Such a skin chiller results in condensation of vapors on the transmitting element that would not be evacuated without employment of an evacuation unit in accordance with the present invention. Alternatively, the skin chiller may be releasably attached to the vacuum chamber.
The increase in light absorption within blood vessels due to the application of a vacuum in the vicinity of a skin target depends on the vacuum level, or the rate of vacuum modulation, and the skin elasticity which is reduced with increased age. As shown, blood vessel 1329 of diameter D is in an underlying position relative to vacuum chamber 1326. By applying a vacuum by means of evacuation unit 1390, blood flow is established in blood vessel 1329 in the direction of arrow M, due to a difference of pressures between points A and B closer and farther from vacuum chamber 1326, respectively. If the blood vessel is a vein, the flow will be established in only one direction, due to the influence of the corresponding vein valve.
According to the Hagen-Poisseuille equation concerning the flow of viscous fluids in tubes, the discharge from a tube and consequently the duration of flow therethrough depends on a pressure gradient along the tube, the fourth power of the diameter of the tube, and the length thereof. For example, diameters of 100 microns are common for capillaries adjacent to the papillary dermis at a depth of approximately 200 microns and 500-micron blood vessel diameters can be found in the hair bulb at a depth of 3 mm. A typical blood vessel length is approximately 1-2 cm. It will be appreciated that although the blood vessel diameters generally increase with depth, the pressure gradient along the blood vessel is smaller at deeper layers of the skin. As a result, for a given pressure, such as the application of a zero millibar vacuum, each depth from the skin surface corresponds to a characteristic time response for being filled by blood. As a result, modulation of the vacuum by opening and closing control valve 1111 (
The operator typically determines an instantaneous modulation frequency of control valves 1108 and 1111 by visually inspecting the skin target and viewing the degree of redness thereat in response to a previous control valve modulation frequency. In addition to improving the treatment efficacy, an increased degree of redness within the skin target advantageously requires a lower energy density of intense pulsed light for achieving blood coagulation or blood heating resulting in the heating of the surrounding collagen. Alternatively, an errythema, i.e. skin redness, meter, e.g. produced by Courage-Hazaka, Germany, may be employed for determining the degree of redness, in order to establish the necessary energy density for the treatment.
For example, a modulation frequency as high as 40 Hz or the firing of a Dye laser unit approximately 1/40 seconds after application of a vacuum may be necessary for applications of port wine stains. In contrast, a delay of approximately a half second for fine wrinkle removal and of approximately 1 second for hair removal may be needed for a depth of 1-3 mm under the skin surface.
When a vacuum is applied to vacuum chamber 200, the pressure differential between the surrounding ambient air pressure and the generated vacuum within the vacuum chamber urges vacuum chamber 200 to be in pressing relation with the skin adjoining skin target 230. The resultant force associated with the pressure differential acts on both legs 240 and on support elements 250. Since a vacuum is applied onto the two sides of support element 250 via volumes V1 and V2, the resultant force transmitted to underlying skin area 210 by support element 250 produces a substantially uniform squeezing pressure. By virtue of thin vacuum volume V2, legs 240 serve as a means to stabilize vacuum chamber 200, which is particularly useful on a skin area that is not completely planar, such as in the vicinity of a bone.
The wide area pressure applied by support element 250 onto skin area 210 directs the expelled blood towards skin target 230 as well as towards leg 240. Air evacuated from volume V1 through inner inlets 282 causes skin target 230 to be proximally drawn and blood to be transported from peripheral skin area 210 towards skin target 230. Support element 250 therefore induces inward blood transport from peripheral skin areas 210 to skin target 230, as represented by arrow 272, resulting in a significant increase in the blood volume fraction within skin target 230. After the blood concentration within skin target 230 has sufficiently increased, light beam 260 is suitable for treating vascular lesions with a wavelength well absorbed by the blood vessels within the skin target, and therefore an energy density less than that of the prior art is fired. The depth of light absorption within skin target 230 can be controlled by changing the thickness T of support elements 250.
Air evacuated from volume V2 through a corresponding outer inlet 284 causes skin area 290 underlying corresponding volume V2 to be drawn drawn proximally. Skin area 290 is then pressed by the edge of support element 250 so that blood, as represented by arrow 292, is outwardly transported from support element 250 to leg 240. By inducing outward transport of blood, the blood volume fraction and therefore the depth of light absorption within skin target 230 may be further controlled.
It will be appreciated that the blood concentration within skin target 230 can be increased solely by the pressure applied by support element 250, without use of legs 240. Likewise, support elements 1325, 1345, and 1502 illustrated in
The absorption of visible intense pulsed light in blood vessels when vacuum is applied to a skin target may be enhanced by the directing electromagnetic waves to the skin target. Radio frequency waves operating in the range of 0.2-10 Mhz are commonly used to coagulate tiny blood vessels. The alternating electrical field generated by a bipolar RF generator, such as produced by Elman, USA or Synron, Canada, follows the path of least electrical resistance, which corresponds to the direction of blood flow within blood vessels. A monopolar RF may also be employed, such as manufactured by Thermage, USA.
RF source 1811 is a bipolar RF generator which generates alternating voltage 1807 applied to skin surface 1802 via wires 1808 and electrodes 1809. Alternatively, the RF source is a monopolar RF generator with a separate ground electrode. Electric field 1810 generally follows the shape of blood vessels 1813, which are the best electrical conductors in the skin. Due to the concentration of blood vessels 1813 in the epidermis, the depth of which below skin surface 1802 depending on the vacuum level and the frequency of vacuum modulation, the combined effect of optical energy in terms of beam 1820 and pulsed RF field 1810 heats or coagulates the blood vessels. Control valve 1804 is regulated by means of control unit 1812. A first command pulse 1 of control unit 1812 controls valve 1804 and a second command pulse 2 controls a delayed radio frequency pulse as well as a delayed light source pulse.
When a vacuum chamber is placed on a skin target, the apparatus provides an additional advantage in terms of the capability of alleviating pain that is normally caused during e.g. the treatment of hair with intense pulsed monochromatic or non-coherent light.
As shown in
It will be appreciated that the application of a suitable vacuum over a skin surface which causes the latter to be flattened by a flat solid surface is physiologically not equivalent to the application of positive pressure over the skin.
Applying a positive pressure onto a skin surface compresses and squeezes the same. Bones located under the skin surface apply a reactive force and therefore contribute to the degree of skin compression, as well as to the squeezing of blood vessels and of nerves bundles. The physiological reaction to the pressing of skin depends on the skin thickness, and particularly, on the distance of the bones from the skin surface.
In contrast, bones underlying a skin surface drawn by a vacuum applied thereto are not influential during a skin flattening procedure. Since the underlying bones do not apply a reactive force as the connective tissue overlying these bones is drawn towards the vacuum chamber, the physiological processes of connective tissue associated with a vacuum induced skin flattening procedure are different than those of connective tissue which is compressed as a result of the application of positive pressure thereto. The applicants are not aware of any published clinical studies which describe the effects of a vacuum induced skin flattening procedure. Any clinical results of a study regarding the application of positive pressure over a skin surface are not expected to be clinically relevant to those obtainable with respect to a vacuum induced skin flattening procedure.
Pain alleviation was evaluated according to a modified McGill pain questionnaire. The McGill pain questionnaire is well known to pain specialists, and is described by R. Melzack, “The McGill Pain Questionnaire: Major Properties and Scoring Methods,” Pain 1 (1975), pp. 277-299. The sensed pain associated with 45 skin targets following a light-based treatment of vacuum-induced flattened skin was compared to the pain associated with light-based treatments conducted without skin flattening. A dramatic pain reduction, from an average of pain level 4, which is indicative of a very painful treatment, to an average of pain level 2, which is indicative of a lack of pain, was revealed.
The applicants have found that an applied vacuum level of at least 150 mmHg, and preferably at least 400 mmHg, is generally needed to alleviate pain. A lower vacuum level, such as of 50 mmHg, which is suitable for blood expulsion, has been found to be not sufficient for the alleviation of pain.
The applicants, have also found that a contributory factor to the level of vacuum-assisted pain reduction is the surface area of the transmitting element. Without wishing to be limited by any particular theory, the inventors believe that the relationship between the level of vacuum-assisted pain reduction and the surface area of the transmitting element is reflected in
The applicants have also surprisingly found that the pain signals cease to be inhibited when the duration of the applied vacuum is longer than a predetermined value. When the duration of the applied vacuum is longer than a value ranging from approximately 0.1-6 seconds, the compression of the drawn skin against the transmitting element does not provide a pain inhibiting effect. An upper limit of the vacuum applying duration is a significant parameter, and prior art vacuum-assisted skin treatment devices are not capable of effectively inhibiting pain transmission, particularly due to the lack of control means for automatically releasing the applied vacuum within the aforementioned duration range. A skin treatment performed with the use of electromagnetic energy is liable to very painful if a pain inhibition signal is not generated during the treatment, i.e. the vacuum chamber, if one exists, is not suitable for drawing skin in compressing fashion against a transmitting element, or the vacuum applying duration is longer than approximately 6 seconds and the delay between the generation of the vacuum and that of the treatment energy directed to the skin target is significantly greater than 6 seconds.
Vacuum chamber 100 illustrated in
The apparatus for alleviating pain during vacuum-assisted light-based treatments of the skin may include a control device (not shown) for adjusting the vacuum level generated by the vacuum pump, as well as the time delay between the application of the vacuum and the firing of light beam. The control device preferably has a plurality of finger depressable buttons, each of which is adapted to set the vacuum pump and light source at a unique combination of operating conditions so as to generate a predetermined vacuum level within vacuum chamber 100 and to result in a predetermined time delay between the operation of the vacuum pump and the firing of light beam 160, and a display to indicate which button was depressed. The apparatus may also comprise control valves in electrical communication with the control device for evacuating air into vacuum chamber during a vacuum applying mode and for introducing air therein during a vacuum release mode, respectively. The health professional is aware of the anticipated pain level that a patient generally senses when one of these buttons is depressed. If the pain threshold of a patient is relatively low or if the application of the vacuum by the vacuum chamber onto the skin target is annoying, the health professional may change the combination of operating conditions by depressing a different button. Alternatively, the pain threshold of a patient may be objectively determined by an electrical measurement of a muscle reflex in response to pain.
As skin target 130 is pressed onto transmitting element 115 during the application of the vacuum, blood is displaced from skin target 130 to peripheral skin area 135. Although the blood fraction volume in peripheral skin area 135 is increased, the latter is nevertheless liable to be damaged by the treatment light, which may diffuse subcutaneously from skin target 130 to skin area 135. To counteract the potential thermal injury to skin area 135, heat absorbing gel (not shown in the figure) is applied to skin target 130 prior to application of the vacuum and is subsequently squeezed to peripheral skin area 135 by means of transmitting element 115. The displaced gel therefore advantageously protects peripheral skin area 135 from being injured by subcutaneously diffused treatment light.
As shown in
Transmitting element 782, which is capable of being in contact with drawn skin 759, may be made from a transparent material coated with a transparent conductive coating, such as produced by Edmund Optics Inc., USA, Melles Griot Inc., USA, or Ophir Optics, Inc., USA, or may be a metallic element. Transmitting element 782 is able to conduct monopolar field 784 generated by RF source 783 through drawn skin 759. Monopolar field 784, which may be generated at an energy density ranging from 1 J/cm2 to 50 J/Cm2 and a frequency ranging from 0.4 MHz to 1 GHz, is perpendicular to the surface of drawn skin 759 and terminates at a return electrode placed on a bodily portion such as the back, as well known to those skilled in the art. For example, monopolar field 784 may be generated at an energy density of 2.4 J/cm2 and a frequency of 2.4 MHz.
Vacuum chamber 755 is configured to induce blood expulsion from the skin target when a vacuum is applied within vacuum chamber 755 above the the skin target. When blood 761, which has relatively low electrical resistance, is expelled in response to the generation of a vacuum of approximately 100 torr, waves of RF energy 783 are able to propagate through the connective tissue or the fatty tissue therebelow of drawn skin 759, rather than being directed through the blood vessels if blood were not expelled. The path of minimal resistance for the flow of electrical current of RF field 784 is therefore not directed through the expelled blood 761, but rather through the connective tissue perpendicular to the upper skin surface. The large proportion of RF energy 783 which is absorbed within drawn skin 759 is able to uniformly heat the collagen-rich reticular dermis and promote skin contraction for the removal of wrinkles. Depending on the depth penetration, which is a function of the frequency of RF source 783 as well known to those skilled in the art, RF field 784 may impinge upon the cellulite or fat level which is disposed below the reticular dermis and cause skin contraction at the cellulite depth or the softening of fat. When a higher-level vacuum of approximately 400 torr is generated, pain signals are inhibited and the treatment is painless.
Vacuum chamber 795 is adapted to expel blood to the periphery thereof, and the connective tissue within drawn skin target 799 is therefore able receives the majority of the energy of RF field 797, which normally would be diverted to the blood vessels located with skin target 799 constituting paths of least electrical resistance without influence of the blood expelling vacuum chamber, so as to achieve an efficacious treatment. A prior art treatment, such as one conducted by Syneron, Israel which utilizes the blood flow path in order to heat portions of the tissue, as explained by N. Sadick et al, “Selective Electro-Thermolysis in Aesthetic Medicine: A Review”, Lasers in Surgery and Medicine 34:91-97 (2004), is not capable of inhibiting pain by the skin flattening technique of the present invention. Similarly, a prior art technique carried out by means of the Aluma produced by Lumenis, USA, and described by M. Goldman in “Treatment of Wrinkles and Skin Tightening using Bipolar Vacuum-Assisted Radio Frequency Heating of the Dermis”, Lumenis, whereby skin is drawn in response to a small vacuum level of 28 mmHg between two parallel electrodes parallel to the skin is not capable of inhibiting pain by the skin flattening technique of the present invention.
As shown in
The diameter of lenses 2155 may vary from 0.5 mm to 3 mm. The negative focal length may be 1-5 times the diameter of the lens. The array is a dense array, such as a hexagonal array of lenses arranged such that each lens is tangential to six adjacent lenses. For 1-mm diameter lenses, the lens density is approximately 1 lens/mm2. Lenses 2155 may be produced from plastic, glass or sapphire and purchased from a large number of lenslet array manufacturers. They may also be produced as a holographic element from HoloOr Ltd., Israel.
An array of lenses 2155 is particularly suitable for skin tightening. When a laser beam generated by an Alexandrite laser having a wavelength of 755 nm or generated by an Nd:YAG laser having a wavelength of 1064 nm wavelength is transmitted through transmitting element 2150 into the flattened skin, the skin target from which blood vessels have been expelled supports a deeper penetration of light and a larger absorption thereof by collagen. Another suitable laser is one identical to a laser produced by DDC Technologies, Inc., USA. Each of these lasers may be operated for a duration of 0.5-5 seconds in order to heat the skin to a temperature of approximately 55° C. at a depth of approximately 1-2 mm. The average laser power is 80 W and the energy density is approximately 15-50 J/cm2.
As shown in
Apparatus for Preventing Gel-Caused Obstruction
The apparatus may be advantageously provided with means to prevent the obstruction of the vacuum chamber conduits by heat releasing gel applied to the skin target prior to the treatment. As shown in
Referring back to
Other arrangements for preventing vacuum pump suction of gel may also be employed. For example, the gel may be bound to a suitable ion exchange resin introduced into trap 1920 and thereby be prevented from being drawn through conduit 1945. If so desired, a filter may be provided at the inlet of conduits 1940 and 1945.
Alternatively, gel may be prevented from exiting the vacuum chamber by increasing the diameter of conduit 1940 at the vacuum wall opening. Consequently, the inwardly directed force acting on the gel which has laterally slid from a drawn skin target by means of the atmospheric air introduced to the vacuum chamber via conduit 1940 during a vacuum release mode is sufficient to prevent the gel from exiting the vacuum chamber. A hydrophobic coating, such as silicon or teflon, may be applied onto the vacuum chamber walls, so that the gel will be prevented from adhering to the vacuum chamber walls, particularly during a vacuum release mode. Instead of adhering to the vacuum chamber walls, the gel falls to the skin surface. Advantageously, gel is therefore not transported to another skin target during the repositioning of the handpiece, but rather assumes the shape of the distal end of the vacuum chamber walls. If the distal end of the vacuum chamber walls is circular, for example, the gel that falls to the skin surface during a vacuum release mode is also circular, indicating to the health professional that is supervising the treatment that the given skin surface has already been impinged by the treatment light.
The vacuum applying mode is initiated upon transmission of signal 445 to controller 440, following which peristaltic pump 430 is activated. Peristaltic pump 430 comprises hose 442 connected to conduit 425 in communication with the interior of vacuum chamber 420 and rotatable hub 446, from which a plurality of shoes and/or rollers 448 (referred to hereinafter as “pressing elements”) radially extend. As hub 446 rotates, the pressing elements sequentially squeeze a different region of hose 442 and a volume of fluid entrapped by two adjacent pressing elements is thereby forced to flow unidirectionally through hose 442 by a positive displacement action towards end 449 thereof. Consequently, when peristaltic pump 430 is activated, air is drawn from the interior of vacuum chamber 420 to generate a vacuum therein ranging from 0-1 atmospheres. If a considerable amount of gel 405 accumulates within the periphery of vacuum chamber 420, the gel is also forced to flow within hose 442 without causing any obstruction to the latter. The gel that is discharged from end 449 of hose 442 falls onto skin surface 410, indicating that an adjoining skin target 415 has undergone a light-based treatment.
Micro-switch 460, or any other suitable skin contact detector, is adapted to sense the placement of the handpiece or of vacuum chamber chamber 420, onto skin target 415. Micro-switch 460 generates signal 445 upon sensing the placement of vacuum chamber 420 on skin target 415. Control valve 450 is triggered by a light detector (not shown), which generates signal 455 upon detecting the termination of the light-based treatment pulse 470. Control valve 450 is opened after the generation of signal 455, to introduce atmospheric pressure air 452 to the interior of vacuum chamber 420 via passageway 456 and to thereby initiate the vacuum release mode. Signal 455 is also transmitted to controller 440, to deactivate peristaltic pump 430. The described automatic operation of peristaltic pump 430 therefore prevents the patient from suffering pain during the associated treatment. If so desired, the operation of peristaltic pump 430 may be manually overridden.
It will be appreciated that a peristaltic pump or a contact detector may be employed in conjunction with any other embodiment of the invention.
In another embodiment, the vacuum pump is an air pump. When air is evacuated from the vacuum chamber, a piston (not shown) which is normally closed by a spring is opened to allow air to be aspirated. During the vacuum release mode, the piston is set to its original position, returning air to the vacuum chamber and any aspirated gel to the skin surface.
When cover 610 is in its lowermost position, as shown in
In this position, air is prevented from infiltrating between cover 610 and skin target 630, e.g. by means of a sealing element externally affixed to walls 620. When a proximally directed force represented by arrows 652 is applied to cover 610, as shown in
Proximally directed force 652 or distally directed force 654 may be generated manually by means of handles (not shown) attached to cover 610, or electrically by means of a plurality of solenoids 670 and/or by means of a spring assembly 660 deployed around the periphery of cover 610, as well known to those skilled in the art to achieve balanced displacement of the cover. Solenoids 670 are mounted such that one side of a solenoid is mechanically connected to displaceable cover 610 and the other side thereof is connected to a chamber wall 620. When electrical actuation of cover 610 is employed, command 608 generated by skin contact sensor 460 (
At times, a sufficiently high vacuum level for effecting a light-based treatment may not be produced within vacuum chamber 640, due to a malfunction. If a health professional notices that the distance between skin target 650 and transmitting element 615 is greater than a predetermined distance for effective treatment with an IPL or laser, the automatic control of cover 610 may be overridden. By reversing the direction of current within solenoids 670, one-time distally directed force 678 may be generated which urges cover 610 towards skin surface 630.
When the distal end of the treatment light source is positioned on chamber walls 620, cover 610 has a relatively low weight of approximately 50 gm. However, if the treatment handpiece is positioned on cover 610 such that the combined weight of the cover and handpiece is approximately 1 kg, the capacity of solenoids 670 needs to be increased, in order to raise both the cover and handpiece and to produce a vacuum within chamber 640.
Apparatus 600 advantageously provides low power consumption and increased compactness. When the handpiece is positioned on chamber walls 620, solenoids 670 are energized by a battery without need of draining wall current and only when cover 610 is needed to be vertically displaced. The energy requirement for raising cover 610 to a height of 2 mm is approximately 0.5 J for a typical 500-pulse large area treatment on the back or legs. Therefore an inexpensive 1.5 V battery is suitable for more than 1000 treatments.
Apparatus 600 also advantageously prevents accumulation of gel. When skin target 650 is drawn during a vacuum applying mode as shown in
The proximally directed force may be supplemented by means of a vacuum pump, which may be needed if an excessive amount of gel is applied to skin surface 630 or if it desired to indicate that skin target 650 has undergone a light-based treatment as described hereinabove.
A Dual Air-Gel Vacuum Pump
Although the gel may provide lubrication for the pump when drawn from the vacuum chamber to the pump cavity, it is desirable that the pump be made from a self-lubricating material to prevent overheating or malfunction thereof since the skin may be covered with a very thin layer of gel, or may not be covered at all by gel, and therefore the pump may not be adequately lubricated.
In the prior art Wankel engines of U.S. Pat. Nos. 5,944,499, 6,106,250, and 6,158,992, each of the three faces of the triangular rotor is involved sequentially with the following four cycles: intake cycle, compression cycle, power cycle and exhaust cycle. Compressible fluids are introduced into an inlet port by the first face of the rotor during the intake cycle, defining a compartment of peak volume between the first face and the casing. At the same time, the second face is driven by the combustion forces and the third face forces out the exhaust gas through the exhaust port. During the compression cycle, the volume of said compartment significantly decreases, causing the introduced fluids to become significantly compressed, whereinafter the compressed fluids are ignited in the power cycle. If an incompressible fluid such as gel were introduced into a Wankel mechanism, the fluid would become excessively pressurized by the force applied by the rotor and the casing during the compression cycle, due to the small chamber volume. The pressurized fluid would then transmit its increased internal force to the rotor, and the apex at the junction of each face is liable to be damaged, e.g. resulting in the formation of a crack, due to the high stress concentration thereat. The pump cover or casing walls are liable to be damaged as well. Prior art Wankel mechanisms are therefore not suitable for reliably delivering incompressible fluids.
In contrast to a prior art Wankel mechanism, the Wankel type vacuum pump of the present invention is suitable for drawing both compressible fluids such as air and incompressible fluids such as gel. Since the rotor is eccentrically mounted, the compartments developed between a rotor face and the surrounding casing have a varying volume, and compressible fluids such as air may therefore be compressed within a compartment having a small volume. In order to accommodate the presence of pressurized gel in a pump compartment having a small volume, the rotor is advantageously formed with a slot in each face. The rotor is therefore able to flex during a compression-exhaust cycle when pressurized gel transmits its increased internal force thereto and thereby prevents rotor failure. The flexing of the rotor also limits the pressure of the gel, which would normally cause the pump cover to separate from the casing if the rotor were not configured with slots and to allow air of atmospheric pressure to infiltrate to the interior of the pump when generating a vacuum.
As shown in
Rotor 865 is formed with end face slots 873A-C and central face slots 883A-C. Each of the end face slots 873A-C is formed in the vicinity of a corresponding apex 868A-C and is substantially perpendicular to the corresponding face 867A-C, causing a discontinuity in the face and dividing the same into two portions 881A-C and 882A-C wherein the shorter portion 881A-C is approximately one-tenth the length of the corresponding longer portion 882A-C. Each of the central face slots 883A-C is formed in rotor 865, adjacent to the centerline of the corresponding face 867A-C and substantially parallel thereto.
Casing 861 is formed with an epitrochoidal inner wall 862 defining a cavity in which rotor 865 rotates. Inner wall 862 is configured such that apexes 868A-C of rotor 865 are in contact with wall 862 throughout the eccentric angular displacement of rotor 865. To ensure that apexes 868A-C of rotor 865 are constantly in contact with inner wall 862 of casing 861, the circumferential length of each of the faces 867A-C is greater than, or equal to, the smallest gap of the rotor cavity between opposite portions of inner wall 862. Since casing 861 and rotor 865 are produced by injection molding to lower production costs, production discrepancies occur at times, e.g. with respect to the operation of the automated production facilities or with a mold formation, causing a discrepancy of up to 0.05 mm. End face slots 873A-C in the vicinity of corresponding apexes 868A-C are formed to ensure that apexes 868A-C on one hand will constantly contact inner wall 862, yet to allow the length of faces 867A-C to contract at regions of inner wall 862 whereat the gap of the rotor cavity is of a reduced dimension.
Three types of compartments G, H, and I, through which a controlled volume of air and gel is sequentially transferred within the pump, are defined by the volume of the cavity between inner wall 862 and a corresponding pair of apexes. Due to the shape of inner wall 862 in which a portion thereof inwardly protrudes, two compartments G are developed, G1 between central face slot 883C and apex 868C and G2 between central face slot 883C and apex 868A. It will be appreciated that other configurations are also suitable wherein only one compartment G is developed.
Compartments G, H, and I are sealed by a Teflon ring surrounding the top and bottom casing covers (not shown), by a Teflon disc having a thickness of approximately 0.1 mm interposed between rotor 865 and each of the top and bottom covers, and additionally by the contact between the apexes and inner wall 862 of the casing.
Pump 860 is operable under three cycles: the intake-expansion cycle, compression-exhaust cycle, and transfer cycle. Each of the compartments undergoes one of these cycles as the corresponding compartment volume changes. In the illustrated orientation of rotor 865, compartment G1 has the smallest volume and is the compartment in which a volume of atmospheric air is transferred in the transfer cycle, compartment H is the compartment in which a volume of air is expanded in the intake-expansion cycle, and compartment I is the compartment in which a volume of air and gel is exhausted in the compression-exhaust cycle. As rotor 865 rotates, air and/or gel are retained in the same compartment and sequentially undergo the compression-exhaust cycle, intake-expansion cycle, and transfer cycle while the volume of said compartment is varied due to the eccentric rotation of rotor 865. Accordingly, in the subsequent cycle to the orientation shown in
Casing 861 is formed with an inlet 887 for each corresponding conduit of a vacuum chamber, through which air and gel are drawn from the interior of the vacuum chamber to the compartment in which a volume of air and gel is received in the intake-expansion cycle, and an outlet 888 through which the air and gel are discharged to exhaust tube 889 during the compression-exhaust cycle. The distal end of exhaust tube 889 is positioned above a corresponding treated skin site. The gel discharged from exhaust tube 889 is therefore directed to a skin area, indicating that said skin area has undergone a light-based vacuum-assisted treatment, so that the treatment handpiece needs to be repositioned to another skin site.
The expansion of air during the intake-expansion cycle generates the vacuum within the vacuum chamber. After atmospheric-pressure air is transferred within a compartment having a relatively small first volume, e.g. compartment G1, to inlet 887, the volume of the retaining compartment is increased to a second volume, and the pressure of the air is accordingly reduced to be subatmospheric. When this second volume communicates with inlet 887, a volume of air and gel is drawn from the vacuum chamber, due to the lower pressure of this second volume. With respect to the illustrated orientation of rotor 865 in
Casing 861 is also provided with exhaust pipe 891 larger in size than exhaust tube 889. Continuous rotation of rotor 865 advantageously directs excessive gel which has not been discharged through exhaust tube 889 to exhaust pipe 891, to prevent the gel from returning to the vacuum chamber. Following additional rotation of rotor 865, air not discharged through exhaust tube 889 or exhaust pipe 891, which may be a volume of less than 5% of the volume of the illustrated compartment I of
As described hereinabove, the pump is capable of evacuating gel from the vacuum chamber.
During the compression-exhaust cycle, the volume of compartment H is sufficiently reduced so as to compress the expanded air 804 (not shown). Due to the considerably reduced volume of compartment H, gel 802A is squeezed between inner wall 862 of casing 861 and face 867A of rotor 865, and therefore becomes pressurized by the opposed force applied thereto by inner wall 862 and face 867A to a very high pressure on the order of 10 atmospheres. Central face slot 883A affords face 867A with sufficient flexibility to prevent the degree of gel pressurization within compartment H during the compression-exhaust cycle. Portion 807 of face 867A in the vicinity of central face slot 883A is consequently inwardly flexed in reaction to the force applied by gel 802A. Since the degree of gel pressurization is limited, the pump cover remains in abutment with casing 861, preventing atmospheric-pressure air to infiltrate to the interior of the pump when generating a vacuum. Furthermore, elastically deformable rotor faces minimize wear of the polymer inner walls 862 of casing 861.
The compressed air and pressurized gel are discharged into exhaust tube 889. Upon further rotation of rotor 865, the pressure of the air and gel not discharged through exhaust tube 889, e.g. when a relatively large amount of gel is drawn to the pump cavity, is reduced. The remaining gel is discharged through exhaust pipe 891, while only a small percentage of the remaining air is not discharged through exhaust pipe 891, but rather is transferred towards inlet 887 during the transfer cycle.
Pump 860 may advantageously restore the pressure within the vacuum chamber to atmospheric pressure within less than 0.1 second, in order to allow the raising and subsequent repositioning of the treatment handpiece. Such a quick pressure restoration is made possible by reversing the rotational direction of rotor 865. The rotational direction of rotor 865 may be reversed by changing the polarity of the pump motor. When an electronic controller controls both the light source and the pump motor, the polarity of the pump motor may be automatically reversed following the transmission of a suitable command by an optical detector, which is adapted to detect the cessation of an optical treatment pulse.
A reversal in the rotational direction of rotor 865 allows atmospheric-pressure air to be delivered from compartment I, when the orientation of rotor is as shown in
As explained hereinabove, pump 860 may be made from inexpensive Acetal mixed with Teflon, and therefore may be disposable. If so desired, pump 860 may be produced from the same types of steel used for Wankel engines.
A handpiece body 362 has a sufficiently small size, low weight and ergonometric design so as to prevent operator fatigue. For example, handpiece body 362 may have a weight of 0.5 kg, a length of 8 cm, a width of 5 cm, and a height of 10-20 cm. Handpiece body 362 is intermittently held by one hand of an operator for more than one hour during repeated repositioning thereof to different skin areas, during vacuum-assisted dermatological treatments of the back or legs. A small handpiece body size also reduces the length of conduit 313 and exhaust tube 389.
The illustrated vacuum chamber 310 is a stand-alone device which is separate from the IPL or laser light source. With such an arrangement, handpiece body 362 is held by one hand and the IPL or laser handpiece is held by the other hand. Motor 340 may be activated by depressing operating button 385 in electrical connection with battery 370, which is positioned in the upper portion of handpiece body 362 and is accessible to a finger of the operator. The rotational direction of motor 340 and consequently of the pump rotor may be reversed e.g. by quickly depressing button 385 twice. The motor may be deactivated by depressing button 385 in a different sequence. Alternatively, pump 360 may be automatically activated by means of sensor 395 in communication with control unit 390, e.g. a skin contact detector, which is adapted to detect the placement of vacuum chamber 310 on a selected skin area. When sensor 395 in communication with control unit 390 is an optical sensor adapted to detect the termination of a light-based treatment pulse, the rotational direction of motor 340 and of the pump rotor may be automatically reversed by means of control unit 390 in order to restore the air pressure within vacuum chamber 310 to atmospheric pressure.
The handpiece system may be embodied such that a single handpiece (not shown) including both the light source and the vacuum pump is used. In this embodiment, the control unit is adapted to control the operation of both the vacuum pump and of the light source. Consequently the control unit can synchronize in sequence a vacuum generating step, a treatment firing step, and a vacuum release step for each treatment cycle. The control unit is therefore suitable for synchronizing a predetermined delay ranging from approximately 0.5 sec to approximately 4 seconds between the activation of the vacuum pump and the firing of the source, in order to ensure that a skin area will be in contact with the transmitting element of the vacuum chamber for a sufficiently long nerve inhibiting duration after the light source is fired. The control unit is also suitable for increasing the pressure in the vacuum chamber to atmospheric pressure by reversing the polarity of the motor following deactivation of the light source.
In another embodiment of the invention, the evacuation of the vacuum chamber may be achieved by means of a peristaltic pump.
As shown, the suction end of Wankel type dermatological air-gel pump 914, or any other suitable rotary or diaphragm pump with similar capabilities, which has a high instantaneous throughput of approximately 5 cm3/0.1 sec, is in communication with vacuum chamber 902 positioned on skin surface 906 via conduit 903. Shaft 926 of dermatological pump 914 is driven by motor 925, which may be an inexpensive reversible direct current (DC) motor. A DC motor can be instantly reversed by reversing its polarity. The vacuum level generated by pump 914 is variable, and is a function of the rotational speed of the rotor of motor 925, which in turn depends on the DC voltage applied thereto. Conduit 903 may be of a short length, e.g. 20 mm if pump 914 is housed within a treatment handpiece, or may be longer, e.g. 3 m if pump 914 is housed within a remote control box, distant from the handpiece, and may be made from Tygon. The discharge end of pump 914 is connected to tube 915, which branches at junction L into hoses 917 and 919. Hose 917 terminates at gel accumulating reservoir 918 and hose 919 terminates at dissolving solution reservoir 931.
In a vacuum applying and pain inhibiting mode, dermatological pump 914 evacuates air and gel from vacuum chamber 902. Gel is discharged through tube 917 and is collected in reservoir 918. Tube 917 is relatively long, e.g. 3 m. Although the gel has excellent lubrication properties and is therefore able to lubricate dermatological pump 914, it tends to dry quickly and to become solid and sticky.
To allow the gel to be reused, a dissolving solution reservoir 931 is provided, which is filled with a cleaning and gel dissolving solution, such as NaCl at a concentration of 2-4%. Peristaltic pump 935 having a relatively low throughput of approximately 200 cm3/10 min is adapted to deliver the dissolving solution from reservoir 931 through hose 919, which is sequentially squeezed by pressing elements of peristaltic pump 935. The dissolving solution is able to flow through hose 917 to gel accumulating reservoir 918 and through tube 915 to dermatological pump 914 and conduit 903. Hose 919 is provided with a check valve (not shown) in the vicinity of junction L, to prevent the flow of gel to reservoir 931. Junction L is typically spaced 2 cm from dermatological pump 914.
The delivery of the dissolving solution to reservoir 918 may be supplemented by means of liquid pump 938 having a relatively low throughput of approximately 200 cm3/10 min, which is installed within an intermediate portion of hose 917 between junction L and reservoir 918. Pump 938, which may be constantly working or in operation for a relatively long period of e.g. 10 minutes, also prevents the backflow of gel from reservoir 918 to dermatological pump 914 during the vacuum release mode.
Dermatological pump 914 may be housed within a handpiece, to increase the mobility of a health professional during a skin treatment, while gel accumulating reservoir 918, dissolving solution reservoir 931, peristaltic pump 935, and liquid pump 938 may be disposed within a remote control box (not shown).
The operation of apparatus 910 is as follows:
It will be appreciated that in addition to the Wankel type, other types of air-gel vacuum pumps may be used as well, such as other types of rotary pumps and diaphragm pumps.
Skin Gliding Apparatus
Some light-based hair removal devices operate at high repetition rates which enable fast treatment by gliding the device over the skin. An example of such a device is the Light Sheer diode laser manufactured by Lumenis which can operate at a repetition rate of 2 pulses per sec. The size of the laser exit beam is approximately 10×10 mm. The laser is highly efficient at 40 J/cm2; however, it is very painful, attaining a pain level of 5.
In a preferred embodiment of the invention, a vacuum chamber is provided with skin gliding apparatus. Very fast and painless treatments may be performed by gliding the laser unit distal end over a sapphire transmitting element at a speed ranging from 0.3-40 cm/sec. A gliding action is made possible by means of a suitable track formed in, or attached to, the transmitting element. The track supports the laser unit distal end, and is adapted to minimize friction between the laser distal end and the transmitting element, and to prevent the latter from being scratched. The skin gliding apparatus is preferably configured in such a way so as to maintain the laser unit distal end in a disposition which is substantially perpendicular with respect to the transmitting element and to prevent overlaps or voids between adjacent spots that are treated by the treatment light. Pain is absent due to the relatively large size of the transmitting element, which ensures that a sufficiently large number of pressure receptors are squeezed so that a signal transmitted therefrom inhibits reception of a pain signal, and due to the relatively high vacuum level. In contrast to prior art treatments wherein immediate sharp pain is felt during each treatment pulse, necessitating a patient to rest during a long delay before continuing the treatment or to be applied with a risky analgesic topical cream, the treatment speed of apparatus of the present invention employing a vacuum chamber need not be slowed.
For example, a vacuum chamber having a size of e.g. 20×40 mm is suitable for inhibiting pain in conjunction with treatment light generated by the Light Sheer diode laser having an energy density of 40 J/cm2. The laser unit distal end may be displaced over a sapphire transmitting element at a speed of 10 mm every 0.5 seconds. The applied vacuum is maintained for a duration of 4 seconds, thereby allowing a skin surface having a similar area of 20×40 mm to be treated by the treatment light without having to release the vacuum.
The displacement of laser distal end 2010 may be externally triggered, i.e. by means of an optical detector that senses the presence of a marker on transmitting element 2025 that corresponds to each target position. Alternatively, laser distal end 2010 is driven by a suitable mechanism at a constant speed of L/t over transmitting element 2025 in free running fashion, i.e. not externally triggered. For example, a laser distal end that produces a 12-mm diameter light beam, such as the Light Sheer of Lumenis, will be driven at a speed of 20 mm/sec if the laser is operated in a free running mode at a 2 Hz repetition rate. In the free running mode, a photodiode may be employed, which is adapted to detect a light pulse generated by the laser and to generate an audible signal being indicative that the laser distal end may be repositioned.
By employing such a configuration of electrodes 951, the RF-assisted IPL or laser unit 955 can be glided upon transmitting element 950 at a high speed of V, e.g. capable of moving a distance of 30 mm within 10 millisec. Convex electrodes 956 of IPL or laser unit 955 will therefore be quickly seated into the corresponding concave portions 953 of electrodes 951 above a selected skin target prior to be treated by light 954.
Some lasers for hair removal such as an Nd:YAG laser produced by Sciton Inc., USA or an Alexandrite laser produced by Lumenis employ a scanner to cover large treatment areas within a short time duration. In accordance with the present invention, a scanning laser can scan the area of a skin surface underlying the transmitting element of the vacuum chamber. Scanning is normally fast, and may reach a repetition rate of 5 pulses/sec. By employing a large transmitting element, application of the vacuum may be maintained for a sufficiently long duration to complete a full scan coverage of a treatment area. As an example, a sapphire transmitting element of 20×40 mm can be used. An Nd:YAG laser with a beam diameter of 10×10 mm will have to scan 8 spots to cover a skin area underlying the transmitting element. The scanning can be achieved within 2 seconds at a repetition rate of 4 pulses/sec. Once scanned, the vacuum is released and the process is repeated at the next skin area. Scanners may also be linear scanners which are less expansive and can utilize either a stepper motor or a galvanometric motor such as produced by Cambridge Technology, Inc., USA.
As described hereinabove, applying a vacuum to the vacuum chamber may either increase or decrease the blood volume fraction within a skin target, depending on a selected configuration of the vacuum chamber. Accordingly, a health professional may employ two differently configured vacuum chambers, each of which is releasably attachable to the same light source handpiece, in order to effect two distinct types of vacuum-assisted light-based treatment, respectively, with a minimum delay to the patient. Thus a single light source and a single vacuum pump may be used for both treatment of vascular lesions by increasing blood concentration within a skin target and for painless hair removal.
In summation, Table I below tabulates the main differences between prior art vacuum-assisted light-based treatment methods, by which ablated skin and vaporous debris are evacuated from a skin target, and that of the present invention:
above 1800 nm
High Vacuum Level
No; evacuated air is
(approximately 0.5 atm)
replaced by fresh air
Automatic Release of
Yes; by means of control
Not necessary due
Vacuum, to Allow
to low vacuum level
Contact between Skin
Yes; for pain alleviation
Employment of Gel
Yes; when skin is not
Suitable for Non-
No; Suitable for
Ablative IPL and
Nd: YAG, Dye,
and Diode Lasers
Array 500 advantageously allows a large-area skin surface, such as of an arm or leg, to be treated by a light source. The treatment light source is sequentially directed to each vacuum chamber 510. Following propagation of the light through a selected vacuum chamber in order to treat a corresponding skin target, the light source may be quickly moved or glided to another skin target without having to move a vacuum chamber and overcoming the force which urges it to the skin surface. Since a vacuum chamber is not displaced, gel is similarly not moved and does not accumulate. Consequently, there is no need to provide means for preventing obstruction of gel within the vacuum pump.
Array 500 is also provided with at least one contact detector (not shown), which triggers a signal to activate the vacuum pump. When the contact detector senses the placement of array 500 on a skin surface, the vacuum pump is activated, and the air from all vacuum chambers 510 is evacuated simultaneously. The health professional then sequentially directs the light source to each vacuum chamber 510. Following completion of the treatment for the entire skin surface, the light source is deactivated and then the vacuum pump is deactivated. Alternatively, each vacuum chamber is provided with a contact detector, two control valves to control the passage of fluid through conduits portions 532 and 534, respectively, and light detector (all of which are not shown). When a treatment handpiece is placed on a transmitting element 540, the corresponding contact detector transmits a signal to activate the vacuum pump, open the control valve which regulates the fluid passage through the corresponding conduit portion 532, and then activates the light source. Upon completion of the light treatment, the light source is deactivated after a predetermined period of time or is manually deactivated. The light detector transmits a signal to close the control valve which regulates the fluid passage through the corresponding conduit portion 532 and to open the control valve which regulates the fluid passage through the corresponding conduit portion 534, in order to release the vacuum. This cycle is repeated for all vacuum chambers 510.
Vacuum-Assisted Photodynamic Therapy
The aforementioned skin flattening process can be used to improve the treatment of skin lesions with photodynamic therapy (PDT) and light which normally has a shallow penetration depth into the skin, such as blue, green or yellow light. Some lesions, such as acne rich with porphyrins, and malignant and precancerous lesions, such as actinic keratosis, can be treated by applying Levulan ALA produced by DUSA Pharmaceuticals, Inc., USA, which is absorbed by the porphyrins so as to be selectively attracted to fast dividing cells, and by photodynamic treatments. The porphyrins are selectively activated by blue light at e.g. 405 nm, by green light at e.g. 514 nm, and by yellow light at e.g. 585 nm. Melanin and blood in the skin normally do not allow light at these wavelengths to penetrate deep into the skin due to strong absorption. By stretching the skin and expelling blood from the skin which is flattened by the cover of the vacuum chamber, light penetration is enhanced and treatment is improved. An array of light emitting diodes such as produced by Philips Lumileds Lighting Company, USA having a power density of 1-20 milliwatts/cm2 may be used.
In another embodiment, the transmitting element of the vacuum chamber is more separated from the skin surface, to prevent the skin target from being flattened. The applied vacuum causes emptying of the sebacious glands of acne lesions. After the vacuum is applied, blue, green or yellow treatment light may be fired, after which a skin flattening light treatment may be performed.
By employing the aforementioned skin flattening procedure, tattoos may be painlessly removed in conjunction with laser or IPL treatment light. Tattoos are often applied over large areas of the skin, such as on half the circumference of an arm, and a large number of patients are desirous of removing the tattoo after a few years. Also, eyebrow tattoos or lip tattoos fade and generally need to be removed prior to applying a new tattoo. Tattoo removal is most efficiently performed with a Q-switched laser, e.g. having an energy density of 10 J/cm2 and a pulse duration of 10 nsec, with a frequency doubled Nd:YAG laser operating at 532 nm for red tattoos or having an energy density of 10 J/cm2 and a pulse duration of 10 nsec for other colored tattoos, or with a Ruby, Alexandrite, or Nd:YAG laser operating at 694 nm, 755 nm, and 1064 nm, respectively, for blue tattoos, a treatment with which is often very painful when the skin target is not flattened in accordance with the method of the present invention.
Prior art wide-area tattoo removal is generally not tolerable and requires the application of a topical analgesic cream such as EMLA which is risky when applied over larger areas. By firing the tattoo removal treatment light through a transparent transmitting element of a vacuum chamber which flattens the skin at a vacuum level suitable for inhibiting pain transmission from the pain receptors in the skin target, tattoo removal from very large skin areas may be performed without any pain and without any interruptions. With use of a pain inhibiting vacuum chamber, significant pain reduction may be noticeable, such as from a pain level of 4 which is very painful to a pain level of 2 which is not painful.
When red tattoos are removed with green laser or IPL light according to prior art methods, blood vessels present in the skin are thermally damaged since red blood vessels absorb green light. The thermal damage often results in bruises which last a few days. In contrast, the skin target does not become bruised during tattoo removal in accordance with the method of the present invention due to the expulsion of blood vessels from the skin target as a result of the skin flattening process. Tattoo removal may be performed with or without the application of gel to the skin surface.
A light beam suitable for tattoo removal having a typical energy density level of 4-13 J/cm2 generally does not generate an excessive amount of heat in the skin or in the transmitting element which is in contact with the flattened skin. As a result, an inexpensive glass or plastic transmitting element may be used since the use of a sapphire transmitting element having high thermal conductivity is unnecessary. Accordingly, an affordable disposable vacuum chamber for tattoo removal may be employed. Due to the superficial bleeding and the resulting skin contamination associated with tattoo removal, the use of a disposable vacuum chamber is quite beneficial. The size of a vacuum chamber for tattoo removal is selected according to the size of the tattooed area and the bodily location, e.g. an eyebrow may require a thin and elongated vacuum chamber. The typical size of a vacuum chamber ranges between 12×20 mm and 25×60 mm, although other sizes may be selected as well. A typical height of the vacuum chamber ranges between 2-8 mm.
The removal of pigmented lesions is very similar to the removal of tattoos. Tattoo removal laser and IPL units are suitable for the removal of pigmented lesions. An IPL unit is generally employed for the removal of pigmented lesions due to its capability of removing unwanted hair with the same unit. The prior art treatment of pigmented lesions is also painful, and the use of a vacuum chamber for is therefore of great utility. The size of a vacuum chamber for the treatment of pigmented lesions is similar to that for tattoo removal. A vacuum chamber which is excessively small, e.g. 5×5 mm, may not efficiently inhibit pain transmission.
An experiment was performed to determine the time response of skin erythema following application of a vacuum onto various skin locations. A pipe of 6 mm diameter was sequentially placed on a hand, eye periphery, arm, and forehead at a subatmospheric pressure of approximately 100 millibar. The skin locations were selected based on the suitability for treatment: the hands and eye periphery for wrinkle removal, arm for hair removal, and forehead for port wine stain treatment. The vacuum was applied for the different periods of time of 1/10, ˝, 1, 2, 3 seconds and then stopped. The erythema level and erythema delay time were then measured.
The response time of the hand and eye periphery was ˝ sec, the response time of the arm was 1 second and the response time of the forehead was ˝ second. Accordingly, the experimental results indicate that the necessary delay between the application of the vacuum and firing of the laser or intensed pulsed light is preferably less than 1 second, so as not to delay the total treatment time, since the repetition rate of most laser or intensed pulsed light sources is generally less than 1 pulse/sec.
The erythema delay time was less than 1 second, and therefore the experimental results indicate that patients will not sense appreciable aesthetic discomfort following treatment in accordance with the present invention.
An intense pulsed light system comprising a broad band Xe flashlamp and a cutoff filter for limiting light transmission between 755 nm and 1200 nm is suitable for aesthetic treatments, such that light delivered through a rectangular light guide is emitted at an energy density of 20 J/cm2 and a pulse duration of 40 milliseconds, for hair removal with respect to a treated area of 15×45 mm.
While efficacy of such a light system for the smoothening of fine wrinkles, i.e. photorejuvenation, is very limited by prior art devices, due to the poor absorption of light by blood vessels at those wavelengths, enhanced light absorption in targeted skin structures in accordance with the present invention would increase the efficacy.
A transparent vacuum chamber of 1 mm height is preferably integrally formed with a handpiece through which intense pulsed light is directed. A diaphragm miniature pump, such as one produced by Richly Tomas which applies a vacuum level of 100 millibar, is in communication with the chamber and a control valve is electronically opened or closed. When the control valve is opened, the pressure in the vacuum chamber is reduced to 100 millibar within less than 10 milliseconds. As a result of the application of vacuum, the skin slightly protrudes into the vacuum chamber at an angle as small as 1/15- 1/45 radian (height divided by size of skin target) and a height of 1 mm. Blood is drawn into the drawn skin target, which achieves a much pinker hue and therefore has a higher light absorbence. The increased redness of the skin increases the light absorption by a factor of 3. As a result, the efficacy of the aforementioned light system is similar to that of a prior art system operating at 60 Joules/cm2, which is known to provide adequate results in wrinkle removal procedures. At energy density levels as high as 20 J/cm2, it is preferable to chill the epidermis in order to avoid a risk of a burn. Epidermis chilling is accomplished by means of an aluminum plate, which is chilled by a thermoelectric chiller. The plate is in contact with the skin and chills the skin just before the handpiece is moved to the chilled skin target, prior to treatment.
The invention has thereby converted an intense pulsed light device for hair removal into an efficient photorejuvenation device as well.
An Nd:YAG laser operating at 1064 nm, 40 milliseconds pulse duration, and energy density of 70 J/cm2 is suitable for prior art hair removal having a spot size of 7 mm. By prior art hair removal, absorption of light in the hair shaft melanin is limited, with a contributory factor in hair removal being attributed to the absorption of light by blood in the hair follicle bulb zone. Since the energy density level of 70 J/cm2 is risky to the epidermis of dark skin, it would be preferable to operate the laser at 40 J/cm2.
A vacuum chamber is preferably integrally formed with a handpiece through which intense pulsed light is directed, at a distance of 1 mm from the skin target. A vacuum is applied to the skin target for 2 seconds. The blood concentration near the follicle bulb and in the bulge at a depth of 4 and 2 mm, respectively, is increased by a factor of 2. As a result the laser is operated with the same efficacy at energy levels closer to 40 J/cm2 and is much safer.
A Dye laser emitting light at a wavelength of 585 nm, with a spot size of 5 mm and pulse duration of 1 microsecond, is used by prior art methods for treatment of vascular lesions, such as telangectasia, and port wine stains, at an energy density level ranging from 10-15 J/cm2 and for the smoothing of wrinkles at an energy density level of 3-4 J/cm2. Some disadvantages of the prior art method are the purpura that is often produced on the skin during vascular treatments and the very large number of treatments (more than 10) which are necessary for the smoothening of wrinkles.
By applying a controlled vacuum to a vacuum chamber in contact with a skin target, having either a moderate vacuum level of approximately 600 millibar or a vacuum which is modulated at a frequency of 10 Hz for 1 seconds prior to the firing of the laser, the efficacy of the laser is enhanced. Consequently it is possible to treat vascular lesions at 7 J/cm2 without creating a purpura and to remove wrinkles with a much smaller number of treatments (5).
A prior art diode laser operated at 810 nm or a Dye laser is suitable for treating vascular rich psoriatic skin, wherein the treated area per pulse is approximately 1 cm2. By employing a vacuum chamber attached to the distal end of the handpiece of either of these lasers, blood is drawn to the lesion and treatment efficacy is improved. The vacuum may be applied for 2 seconds prior to firing the laser beam.
A deep penetrating laser, such as a pulsed diode laser at 940 nm, an Nd:YAG laser, or an intense pulsed light source operating at an energy density of 30 J/cm2, is suitable for thermally damaging a gland, when a vacuum chamber is attached to the distal end of the handpiece thereof. When vacuum is applied for a few seconds, e.g. 1-10 seconds, above a gland such as a sweat gland, excessive blood is drawn into the gland. After the pulsed laser beam is directed to the skin, the absorption of the laser beam by the drawn blood generates heat in the gland, which is thereby damaged. It is therefore possible to more efficiently thermally damage glands with a laser or intense pulsed light source when vacuum is applied to the skin.
By placing a vacuum chamber on a skin target in accordance with the present invention prior to the firing of an intense pulsed light source, the treatment energy density level for various types of treatment is significantly reduced with respect with that associated with prior art devices. The treatment energy density level is defined herein as the minimum energy density level which creates a desired change in the skin structure, such as coagulation of a blood vessel, denaturation of a collagen bundle, destruction of cells in a gland, destruction of cells in a hair follicle, or any other desired effects.
The following is the treatment energy density level for various types of treatment performed with use of the present invention and with use of prior art devices:
A vacuum chamber made of polycarbonate having a length of 50 mm, a width of 25 mm, a height of 3 mm, and a transmitting element made of sapphire was used during the treatment of unwanted hairs of 5 patients with an intense pulsed light system which emitted energy in the spectral band of 670-900 nm. A thin layer of gel at room temperature having a thickness of 0.5 mm was applied to a skin target. The suction openings had a diameter of 1 mm and were formed in the vacuum chamber walls at a height of 0.5 mm below the transmitting element, in order to prevent the obstruction of the openings by gel or by the drawn skin. A small canister serving as a gel trap was provided intermediate to the fluid passage between the vacuum chamber and the vacuum pump, to prevent gel from being drawn to the inlet port of the vacuum pump. A vacuum level of 500 mmHg was generated within the vacuum chamber and caused the skin target to be drawn in contact with the transmitting element.
An intense pulsed light system having a treatment beam length of 40 mm and width of 15 mm was fired with an energy density of 16-20 J/cm2 and a pulse duration of 30-40 milliseconds. One patient underwent a back hair removal treatment, wherein areas of the back were treated as a control without application of a vacuum onto the skin surface and other areas were treated while a vacuum was applied to the skin surface. The other patients underwent a hair removal treatment on their legs, chest and abdomen such that a vacuum was applied to some areas, while the treatment of an adjacent area was not vacuum assisted, as a control. For all five patients, a skin chiller was not employed.
The pain sensation of the patients was categorized into five levels: Level 0 indicating that pain was not felt at all, Level 5 indicating that pain was untolerable after a few laser shots whereby a patient grimaced and uncontrollably reacted after each shot, Level 1 indicating that the treatment was sensed but without pain, and Levels 2, 3, and 4 indicating an increasing level of pain. All of the patients consistently suffered Pain Level 3-5 when a vacuum was not applied, and the pain was alleviated (Level 2) or was completely prevented (Level 1 or 0) when a vacuum was applied. Pain alleviation was found to be dependent on the time delay between the application of the vacuum and the firing of the intense pulsed light. Pain alleviation was sensed when the intense pulsed light was fired at least 1.5 seconds after application of the vacuum onto the skin surface.
A patient undergoing a hair removal treatment was tested for pain sensitivity. An intense pulsed Diode laser (Light Sheer, Lumenis) operating at 810 nm was employed. A vacuum chamber made of polycarbonate having a length of 40 mm, a width of 15 mm, a height of 3 mm, and a transmitting element made of sapphire was used. A thin layer of gel at room temperature having a thickness of 0.5 mm was applied to a skin target. The suction openings had a diameter of 1 mm and were formed in the vacuum chamber walls at a height of 0.5 mm below the transmitting element. A small canister serving as a gel trap was provided intermediate to the fluid passage between the vacuum chamber and the vacuum pump, to prevent gel from being drawn to the inlet port of the vacuum pump.
When a vacuum was not applied to the skin target and the light source operated at an energy density of 42 J/cm2 and a pulse duration of 30 milliseconds, the patient sensed a Pain Level of 5. When a vacuum level of 500 mmHg was generated within the vacuum chamber causing the skin target to be drawn in contact with the transmitting element and the light source operated at an energy density of 42 J/cm2 and a pulse duration of 30 milliseconds, the patient sensed a considerably reduced Pain Level of 2. This reduced pain level during the vacuum assisted treatment was found to be equivalent to the mild pain sensed when the light source operated at an energy density of only 26 J/cm2 and a pulse duration of 30 milliseconds and a vacuum was not applied to the skin target.
The pain level distribution resulting from a light-based, vacuum-assisted skin flattening skin treatment was compared to that resulting from a conventional light-based skin treatment. Light generated by an IPL Lovely unit manufactured by Msq Ltd., Israel and having an energy density of 18 J/cm2, a wavelength greater than 640 nm, and a pulse duration of 30 msec was directed to 41 different skin targets. Light generated by an Alexandrite laser unit having an energy density of 25 J/cm2 and a pulse duration of 3 msec was directed to 2 different skin targets. Light generated by a diode laser having an energy density of 42 J/cm2 and a pulse duration of 2 msec was directed to 2 different skin targets. To 27 of those skin targets a vacuum of 500 mmHg was applied by means of a vacuum chamber having a planar, 20×50 mm sapphire transmitting element such that the skin target was flattened by the transmitting element. The skin treatment of the remaining 18 targets was performed without generation of a vacuum.
The influence of the vacuum level during a skin flattening skin treatment on the perceived pain level was tested. Light generated by an IPL Lovely unit manufactured by Msq. Ltd., Israel and having an energy density of 18 J/cm2, a wavelength greater than 640 nm, and a pulse duration of 30 msec was directed to 10 different skin targets. The pain sensation was evaluated according to a modified McGill pain questionnaire. Table II below reflects the average pain level reduction that was perceived for the different vacuum levels that were applied to each of the 10 skin targets.
At a vacuum level of approximately 150 mmHg, the perceived average pain level was 4. The perceived pain level was further reduced to a pain level of 3 when a vacuum level of 300 mmHg was applied, and a significant pain reduction to a pain level of 2 was achieved when a vacuum level of 500 mmHg was applied.
Applied Vacuum (mmHg)
Level of Pain Reduction
The influence of the surface area of the transmitting element during a skin flattening skin treatment on the perceived pain level was tested. Light generated by an IPL Lovely unit manufactured by Msq Ltd., Israel and having an energy density of 18 J/cm2, a wavelength greater than 640 nm, and a pulse duration of 30 msec was directed to 10 different skin targets. Light generated by a diode laser having an energy density of 42 J/cm2 and a pulse duration of 2 msec was directed to 2 different skin targets. The vacuum level that was applied to each of the skin targets was 500 mmHg. The pain sensation was evaluated according to a modified McGill pain questionnaire.
For a transmitting element of 9×9 mm, the average perceived pain level was 3. For a transmitting element of 12×20 mm, the average perceived pain level was a tolerable 2-3. For a transmitting element of 20×40 mm, the average perceived pain level was 1-2, which was nearly without any pain.
The casing of a tested Wankel type vacuum pump in accordance with the present invention had a width of 50 mm, a length of 50 mm, and a height of 10 mm. The length of the central face slots 8 83A was 20 mm. The rotational speed of the pump rotor was 1500 rpm, or 25 revolutions per second, which was achieved by means of a small brushless motor. At such a rotational speed, the evacuation rate was 18 cm3/sec for an average volume of a vacuum generating compartment of 0.25 cm3. This evacuation rate is suitable for evacuating a vacuum chamber having typical dimensions of 20 mm×40 mm×5 mm height, or a typical volume of 4 cm3, within approximately 0.2 seconds. Since the vacuum needs to be generated prior to the firing of a light-based treatment pulse, the treatment speed was able to exceed a rate of 1 Hz. For a 500-pulse treatment and an average vacuum generation duration of 1 second for each treatment pulse, 12,500 rotor revolutions are needed. Plastic materials with a low friction coefficient of e.g. 0.1 wear only after approximately 50,000 revolutions, and therefore the pump is certainly durable for a 500-pulse treatment.
While some embodiments of the invention have been described by way of illustration, it will be apparent that the invention can be carried into practice with many modifications, variations and adaptations, and with the use of numerous equivalents or alternative solutions that are within the scope of persons skilled in the art, without departing from the spirit of the invention or exceeding the scope of the claims.
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|U.S. Classification||601/6, 601/7, 601/15|
|International Classification||A61N5/067, A61H7/00, A61H23/02, A61B18/20, A61N5/06|
|Cooperative Classification||A61H9/0057, A61B17/205, A61M5/425, A61B2018/00291, A61H9/005, A61B2017/00752, A61B2018/00005, A61B18/203, A61N7/00, A61B2017/306, A61B2018/00476, A61B2018/00458, A61M5/422, A61N2007/0008, A61B2017/00747, A61H7/008, A61B18/14, A61B2018/00452|
|European Classification||A61H9/00P, A61M5/42B, A61B17/20B, A61M5/42C, A61H7/00K2, A61H9/00P1, A61B18/20H|
|8 Jul 2008||AS||Assignment|
Owner name: INOLASE LTD., ISRAEL
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|11 Mar 2009||AS||Assignment|
Owner name: CANDELA CORPORATION, MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:INOLASE LTD.;REEL/FRAME:022368/0678
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|28 Jan 2014||FPAY||Fee payment|
Year of fee payment: 4
|20 Sep 2017||AS||Assignment|
Owner name: ING CAPITAL LLC, AS COLLATERAL AGENT, NEW YORK
Free format text: SECURITY AGREEMENT;ASSIGNORS:SYNERON MEDICAL LTD.;CANDELA CORPORATION;PRIMAEVA CORPORATION;REEL/FRAME:043925/0001
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